Trial Outcomes & Findings for Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. (NCT NCT01756456)
NCT ID: NCT01756456
Last Updated: 2024-04-19
Results Overview
Complete healing of the PED or corneal ulcer was determined by corneal fluorescein staining at 4 weeks as defined by the reading center evaluating the clinical pictures. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm at the Week 4 visit. The primary efficacy variable was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
174 participants
Primary outcome timeframe
at 4 weeks of treatment
Results posted on
2024-04-19
Participant Flow
The study consisted of 2 periods: 8week PhaseI/controlled treatment period and 48/56-week FU period. In the Phase1 patients were randomized into 2 cohorts (of 9 pts each). In phase 2 pts were randomized in a 1:1:1 ratio (52 pts each group). Data refer to the 1st database lock when the last patient in Phase2 had completed 12 weeks of FU period.
The inclusion/exclusion criteria were designed to include individuals 18 years of age or older with Stage 2 (PED) or Stage 3 (corneal ulcer) NK involving only 1 eye and to exclude those with Stage 2 or 3 NK affecting both eyes, any active ocular infection or inflammation not related to NK, or any ocular disease or severe vision loss.
Participant milestones
| Measure |
1_rhNGF 10µg/ml Phase 1_treatment
rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
2_rhNGF 20 µg/ml_Phase 1_treatment
rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
3_vehicle group_Phase 1_treatment
Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
4_rhNGF10_Phase 2_treatment
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
|---|---|---|---|---|---|---|
|
Treatment Period: Phase I/II
STARTED
|
7
|
7
|
4
|
52
|
52
|
52
|
|
Treatment Period: Phase I/II
COMPLETED
|
6
|
6
|
2
|
45
|
39
|
48
|
|
Treatment Period: Phase I/II
NOT COMPLETED
|
1
|
1
|
2
|
7
|
13
|
4
|
|
Follow Up Period Phase I/II
STARTED
|
6
|
6
|
2
|
45
|
39
|
48
|
|
Follow Up Period Phase I/II
COMPLETED
|
5
|
5
|
1
|
12
|
13
|
15
|
|
Follow Up Period Phase I/II
NOT COMPLETED
|
1
|
1
|
1
|
33
|
26
|
33
|
Reasons for withdrawal
| Measure |
1_rhNGF 10µg/ml Phase 1_treatment
rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
2_rhNGF 20 µg/ml_Phase 1_treatment
rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
3_vehicle group_Phase 1_treatment
Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
4_rhNGF10_Phase 2_treatment
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
|---|---|---|---|---|---|---|
|
Treatment Period: Phase I/II
decision unrelated to adverse event
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Treatment Period: Phase I/II
Lack of Efficacy
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Treatment Period: Phase I/II
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period: Phase I/II
Adverse Event
|
1
|
0
|
2
|
3
|
9
|
1
|
|
Treatment Period: Phase I/II
Other causes
|
0
|
0
|
0
|
1
|
2
|
2
|
|
Follow Up Period Phase I/II
still in study after week 20
|
0
|
0
|
0
|
25
|
23
|
25
|
|
Follow Up Period Phase I/II
parent withdrew the consent to continue
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow Up Period Phase I/II
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Follow Up Period Phase I/II
Adverse Event
|
1
|
0
|
0
|
5
|
0
|
1
|
|
Follow Up Period Phase I/II
Lost to Follow-up
|
0
|
0
|
1
|
2
|
0
|
1
|
|
Follow Up Period Phase I/II
Other causes
|
0
|
0
|
0
|
1
|
3
|
5
|
Baseline Characteristics
The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
Baseline characteristics by cohort
| Measure |
1_rhNGF10_Phase 1_treatment
n=7 Participants
rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
2_rhNGF20_Phase 1_treatment
n=7 Participants
rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
3_vehicle group_Phase 1_treatment
n=4 Participants
Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
6_vehicle group_Phase 2_treatment
n=52 Participants
Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age continuous
|
61.7 years
STANDARD_DEVIATION 21.47 • n=93 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
52.0 years
STANDARD_DEVIATION 17.24 • n=4 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
64.3 years
STANDARD_DEVIATION 24.06 • n=27 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
59.0 years
STANDARD_DEVIATION 17.17 • n=483 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
62.5 years
STANDARD_DEVIATION 14.01 • n=36 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
60.4 years
STANDARD_DEVIATION 16.78 • n=10 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
58.5 years
STANDARD_DEVIATION 19.98 • n=115 Participants • The patients populations of Phase I and Phase II are different. The first consists of 18 individuals, the second of 156 individuals.
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
35 Participants
n=10 Participants
|
104 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
17 Participants
n=10 Participants
|
70 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
41 Participants
n=10 Participants
|
141 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: at 4 weeks of treatmentPopulation: Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).
Complete healing of the PED or corneal ulcer was determined by corneal fluorescein staining at 4 weeks as defined by the reading center evaluating the clinical pictures. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm at the Week 4 visit. The primary efficacy variable was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
Yes
|
55 percentage of subjects
|
58 percentage of subjects
|
20 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
No
|
45 percentage of subjects
|
42 percentage of subjects
|
80 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 4 weeks of study treatment.Population: Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).
Complete healing of the PED or corneal ulcer at 4 weeks as defined by the Investigator. The complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer, being less than 0.5 mm at the Week 4 visit. This secondary outcome was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
Yes
|
52 percentage of subjects
|
61 percentage of subjects
|
26 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
No
|
48 percentage of subjects
|
39 percentage of subjects
|
74 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 6 and 8 weeks after start of the treatmentPopulation: Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).
Complete healing of the PED or corneal ulcer at 6 and 8 weeks measured by both the central reading center and Investigator. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm. This outcome was analyzed after 6 and 8 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 6 - investigator - no
|
39 percentage of subjects
|
36 percentage of subjects
|
59 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 8 - central reading center - no
|
22 percentage of subjects
|
17 percentage of subjects
|
44 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 6 - central reading center - yes
|
68 percentage of subjects
|
60 percentage of subjects
|
66 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 6 - central reading center - no
|
32 percentage of subjects
|
40 percentage of subjects
|
34 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 6 - investigator - yes
|
61 percentage of subjects
|
64 percentage of subjects
|
41 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 8 - central reading center - yes
|
78 percentage of subjects
|
83 percentage of subjects
|
56 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 8 - investigator - yes
|
79 percentage of subjects
|
79 percentage of subjects
|
53 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
week 8 - investigator - no
|
21 percentage of subjects
|
21 percentage of subjects
|
47 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 4, 6 and 8 weeks after start of the treatmentPopulation: ITT population
Complete corneal clearing (grade 0 on the modified Oxford scale) at 4, 6 and 8 weeks. A patient was considered to have achieved complete corneal clearing if he/she had a Modified Oxford Scale recorded as Grade 0. The scale has the following grades: 0-1-2-3-4-5, where 5 represents the worst outcome value and 0 the best outcome value.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Experiencing Complete Corneal Clearing
week 4 - yes
|
0 percentage of subjects
|
17 percentage of subjects
|
33 percentage of subjects
|
21 percentage of subjects
|
20 percentage of subjects
|
7 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Corneal Clearing
week 4 - no
|
100 percentage of subjects
|
83 percentage of subjects
|
67 percentage of subjects
|
79 percentage of subjects
|
80 percentage of subjects
|
93 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Corneal Clearing
week 6 - yes
|
17 percentage of subjects
|
14 percentage of subjects
|
0 percentage of subjects
|
24 percentage of subjects
|
23 percentage of subjects
|
8 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Corneal Clearing
week 6 - no
|
83 percentage of subjects
|
86 percentage of subjects
|
100 percentage of subjects
|
76 percentage of subjects
|
77 percentage of subjects
|
92 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Corneal Clearing
week 8 -yes
|
17 percentage of subjects
|
14 percentage of subjects
|
0 percentage of subjects
|
27 percentage of subjects
|
21 percentage of subjects
|
10 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Complete Corneal Clearing
week 8 - no
|
83 percentage of subjects
|
86 percentage of subjects
|
100 percentage of subjects
|
73 percentage of subjects
|
79 percentage of subjects
|
90 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At screening and at week 8Population: ITT population
Mean changes in Best-Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8 are calculated as Least Square means. BCDVA consists of letters read at 4 meters only. Patients are scored by how many letters could be correctly identified. Therefore the higher the number of letters, the higher the visual acuity.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in Best Corrected Distance Visual Acuity (BCDVA)
|
15.8 LogMAR
Standard Error 2.58
|
11.9 LogMAR
Standard Error 2.80
|
6.9 LogMAR
Standard Error 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 4, 6 and 8 weeks.Population: ITT population
Percentage of patients that achieve an improvement in corneal sensitivity as measured by the Cochet-Bonnet aesthesiometer
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
week 8 - no
|
33 percentage of subjects
|
40 percentage of subjects
|
0 percentage of subjects
|
21 percentage of subjects
|
24 percentage of subjects
|
32 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
week 4 - yes
|
67 percentage of subjects
|
50 percentage of subjects
|
50 percentage of subjects
|
69 percentage of subjects
|
61 percentage of subjects
|
63 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
week 4 - no
|
33 percentage of subjects
|
50 percentage of subjects
|
50 percentage of subjects
|
31 percentage of subjects
|
39 percentage of subjects
|
37 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
week 6 - yes
|
67 percentage of subjects
|
50 percentage of subjects
|
50 percentage of subjects
|
83 percentage of subjects
|
68 percentage of subjects
|
55 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
week 6 - no
|
33 percentage of subjects
|
50 percentage of subjects
|
50 percentage of subjects
|
17 percentage of subjects
|
32 percentage of subjects
|
45 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
week 8 -yes
|
67 percentage of subjects
|
60 percentage of subjects
|
100 percentage of subjects
|
79 percentage of subjects
|
76 percentage of subjects
|
68 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: from baseline to Week 4, 6, and 8.Population: ITT population
Percentage of patients experiencing deterioration (increase in lesion size ≥ 1mm, decrease in BCDVA by \>5 ETDRS letters, progression in lesion depth to corneal melting or perforation, onset of infection) in stage 2 or 3 NK from baseline to Week 4, 6, and 8.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
week 4 - yes
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
2 percentage of subjects
|
2 percentage of subjects
|
5 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
week 4 - no
|
100 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
98 percentage of subjects
|
98 percentage of subjects
|
95 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
week 6 - yes
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
2 percentage of subjects
|
0 percentage of subjects
|
10 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
week 6 - no
|
100 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
98 percentage of subjects
|
100 percentage of subjects
|
90 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
week 8 -yes
|
0 percentage of subjects
|
14 percentage of subjects
|
0 percentage of subjects
|
4 percentage of subjects
|
7 percentage of subjects
|
15 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
week 8 - no
|
100 percentage of subjects
|
86 percentage of subjects
|
100 percentage of subjects
|
96 percentage of subjects
|
93 percentage of subjects
|
85 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at week 20/28, 32/40, 44/52, and 56/64Population: ITT population
Percentage of patients achieving complete healing of the PED or corneal ulcer by Week 8/16 that remain healed (ie, no recurrence of the PED and/or corneal ulcer) at Weeks 20/28, 32/40, 44/52, 56/64
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 20/28 - no
|
0 percentage of subjects
|
25 percentage of subjects
|
0 percentage of subjects
|
13 percentage of subjects
|
11 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 32/40 - yes
|
100 percentage of subjects
|
75 percentage of subjects
|
100 percentage of subjects
|
78 percentage of subjects
|
92 percentage of subjects
|
100 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 44/52 - no
|
0 percentage of subjects
|
20 percentage of subjects
|
0 percentage of subjects
|
33 percentage of subjects
|
12 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 56/64 - yes
|
100 percentage of subjects
|
80 percentage of subjects
|
100 percentage of subjects
|
67 percentage of subjects
|
82 percentage of subjects
|
100 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 20/28 - yes
|
100 percentage of subjects
|
75 percentage of subjects
|
100 percentage of subjects
|
87 percentage of subjects
|
89 percentage of subjects
|
100 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 32/40 - no
|
0 percentage of subjects
|
25 percentage of subjects
|
0 percentage of subjects
|
22 percentage of subjects
|
8 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 44/52 - yes
|
100 percentage of subjects
|
80 percentage of subjects
|
100 percentage of subjects
|
67 percentage of subjects
|
88 percentage of subjects
|
100 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
week 56/64 - no
|
0 percentage of subjects
|
20 percentage of subjects
|
0 percentage of subjects
|
33 percentage of subjects
|
18 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at week 4 and 8Population: ITT population
Global evaluation of efficacy as assessed by the Investigator at 4 and 8 weeks. The different level of efficacy were: very good; good; moderate; poor; non-evaluable.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 8 - good
|
33 percentage of subjects
|
43 percentage of subjects
|
50 percentage of subjects
|
31 percentage of subjects
|
45 percentage of subjects
|
20 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 4 - poor
|
33 percentage of subjects
|
29 percentage of subjects
|
0 percentage of subjects
|
6 percentage of subjects
|
10 percentage of subjects
|
19 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 4 - non-evaluable
|
0 percentage of subjects
|
0 percentage of subjects
|
33 percentage of subjects
|
2 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 8 - very good
|
17 percentage of subjects
|
29 percentage of subjects
|
50 percentage of subjects
|
48 percentage of subjects
|
40 percentage of subjects
|
40 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 8 - moderate
|
33 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
12 percentage of subjects
|
5 percentage of subjects
|
12 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 8 - poor
|
17 percentage of subjects
|
29 percentage of subjects
|
0 percentage of subjects
|
4 percentage of subjects
|
10 percentage of subjects
|
28 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 8 - non-evaluable
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
4 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 4 - very good
|
17 percentage of subjects
|
29 percentage of subjects
|
67 percentage of subjects
|
40 percentage of subjects
|
34 percentage of subjects
|
26 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 4 - good
|
33 percentage of subjects
|
43 percentage of subjects
|
0 percentage of subjects
|
38 percentage of subjects
|
49 percentage of subjects
|
35 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
week 4 - moderate
|
17 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
15 percentage of subjects
|
7 percentage of subjects
|
21 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline and at weeks 8 and 20Population: Safety population
Ocular tolerability was recorded by the patient on a VAS scale from 0 to 100 mm, where a higher VAS score indicates worse ocular symptoms (0 means no symptoms and 100 means the worst possible discomfort). The overall VAS score for ocular tolerability was calculated as the mean of the individual VAS scores for the 7 different symptoms (foreign body sensation, burning/stinging, itching, ocular pain, sticky feeling, blurred vision and photophobia). Results are below reported as per symptoms at week 8 (for treatment period) and week 20 (for Follow Up period).
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
n=6 Participants
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
n=6 Participants
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
n=2 Participants
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
n=45 Participants
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
n=39 Participants
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
n=48 Participants
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
burning/stinging_baseline
|
41.4 VAS score
Standard Deviation 30.85
|
30.7 VAS score
Standard Deviation 38.78
|
18 VAS score
Standard Deviation 28.57
|
32.5 VAS score
Standard Deviation 32.88
|
26.5 VAS score
Standard Deviation 30.86
|
30.2 VAS score
Standard Deviation 32.21
|
41.4 VAS score
Standard Deviation 30.85
|
30.7 VAS score
Standard Deviation 38.78
|
18 VAS score
Standard Deviation 28.57
|
32.5 VAS score
Standard Deviation 32.88
|
26.5 VAS score
Standard Deviation 30.86
|
30.2 VAS score
Standard Deviation 32.21
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
Foreign Body Sensation_Baseline
|
50.4 VAS score
Standard Deviation 25.68
|
24 VAS score
Standard Deviation 19.76
|
20.5 VAS score
Standard Deviation 29.23
|
34.8 VAS score
Standard Deviation 29.4
|
35.4 VAS score
Standard Deviation 34.79
|
37.7 VAS score
Standard Deviation 36.49
|
50.4 VAS score
Standard Deviation 25.68
|
24 VAS score
Standard Deviation 19.76
|
20.5 VAS score
Standard Deviation 29.23
|
34.8 VAS score
Standard Deviation 29.4
|
35.4 VAS score
Standard Deviation 34.79
|
37.7 VAS score
Standard Deviation 36.49
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
Foreign Body Sensation_CFB
|
-21.2 VAS score
Standard Deviation 25.96
|
-12.9 VAS score
Standard Deviation 17.03
|
-16 VAS score
Standard Deviation 65.05
|
-8.8 VAS score
Standard Deviation 34.68
|
-16.5 VAS score
Standard Deviation 36.87
|
-20.9 VAS score
Standard Deviation 35.86
|
-20 VAS score
Standard Deviation 30.32
|
-13 VAS score
Standard Deviation 25.3
|
-52 VAS score
Standard Deviation 0
|
-16.6 VAS score
Standard Deviation 31.26
|
-22.4 VAS score
Standard Deviation 38.77
|
-20.7 VAS score
Standard Deviation 30.57
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
burning/stinging_CFB
|
-14.7 VAS score
Standard Deviation 38.02
|
-12.1 VAS score
Standard Deviation 28.27
|
-28.5 VAS score
Standard Deviation 23.33
|
-3.8 VAS score
Standard Deviation 42.13
|
-2.5 VAS score
Standard Deviation 26.76
|
-18 VAS score
Standard Deviation 32.97
|
-18 VAS score
Standard Deviation 41.65
|
-16.5 VAS score
Standard Deviation 17.13
|
-12 VAS score
Standard Deviation 0
|
-14.9 VAS score
Standard Deviation 40.35
|
-10.8 VAS score
Standard Deviation 31.51
|
-14.7 VAS score
Standard Deviation 37.54
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
itching_baseline
|
17 VAS score
Standard Deviation 27.4
|
18.7 VAS score
Standard Deviation 19.62
|
7.8 VAS score
Standard Deviation 15.5
|
24.1 VAS score
Standard Deviation 27.48
|
21.8 VAS score
Standard Deviation 28.68
|
22.9 VAS score
Standard Deviation 28.43
|
17 VAS score
Standard Deviation 27.4
|
18.7 VAS score
Standard Deviation 19.62
|
7.8 VAS score
Standard Deviation 15.5
|
24.1 VAS score
Standard Deviation 27.48
|
21.8 VAS score
Standard Deviation 28.68
|
22.9 VAS score
Standard Deviation 28.43
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
itching_CFB
|
-3 VAS score
Standard Deviation 17.93
|
-10 VAS score
Standard Deviation 23.1
|
-15.5 VAS score
Standard Deviation 21.92
|
-10.8 VAS score
Standard Deviation 29.25
|
-7.3 VAS score
Standard Deviation 22.67
|
-8.9 VAS score
Standard Deviation 25.59
|
-7.8 VAS score
Standard Deviation 27.18
|
-4.2 VAS score
Standard Deviation 28.51
|
-31 VAS score
Standard Deviation 0
|
-10.2 VAS score
Standard Deviation 30.62
|
-11.9 VAS score
Standard Deviation 23.05
|
-4.8 VAS score
Standard Deviation 30.71
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
ocular pain_baseline
|
34.1 VAS score
Standard Deviation 36.96
|
33.6 VAS score
Standard Deviation 34.73
|
19 VAS score
Standard Deviation 38
|
32.8 VAS score
Standard Deviation 34.86
|
21.1 VAS score
Standard Deviation 28.38
|
28.8 VAS score
Standard Deviation 32.82
|
34.1 VAS score
Standard Deviation 36.96
|
33.6 VAS score
Standard Deviation 34.73
|
19 VAS score
Standard Deviation 38
|
32.8 VAS score
Standard Deviation 34.86
|
21.1 VAS score
Standard Deviation 28.38
|
28.8 VAS score
Standard Deviation 32.82
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
ocular pain_CFB
|
-21.2 VAS score
Standard Deviation 28.96
|
-6 VAS score
Standard Deviation 30.72
|
-23 VAS score
Standard Deviation 32.53
|
-2 VAS score
Standard Deviation 43
|
2 VAS score
Standard Deviation 37.25
|
-16.3 VAS score
Standard Deviation 30.52
|
-16 VAS score
Standard Deviation 28.59
|
-9.3 VAS score
Standard Deviation 11.86
|
-26 VAS score
Standard Deviation 0
|
-16.7 VAS score
Standard Deviation 34.66
|
-12.1 VAS score
Standard Deviation 31.25
|
-18.3 VAS score
Standard Deviation 34.3
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
sticky feeling_baseline
|
47.6 VAS score
Standard Deviation 34.14
|
32.1 VAS score
Standard Deviation 35.34
|
15.5 VAS score
Standard Deviation 23.69
|
26.6 VAS score
Standard Deviation 29.65
|
17.4 VAS score
Standard Deviation 22.07
|
26.1 VAS score
Standard Deviation 31.93
|
47.6 VAS score
Standard Deviation 34.14
|
32.1 VAS score
Standard Deviation 35.34
|
15.5 VAS score
Standard Deviation 23.69
|
26.6 VAS score
Standard Deviation 29.65
|
17.4 VAS score
Standard Deviation 22.07
|
26.1 VAS score
Standard Deviation 31.93
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
sticky feeling_CFB
|
-7.2 VAS score
Standard Deviation 42.82
|
-18.7 VAS score
Standard Deviation 38.32
|
-11 VAS score
Standard Deviation 5.66
|
-11.7 VAS score
Standard Deviation 30.17
|
-4.3 VAS score
Standard Deviation 29.55
|
-10.7 VAS score
Standard Deviation 29.95
|
-19.8 VAS score
Standard Deviation 22.18
|
-0.7 VAS score
Standard Deviation 12.52
|
-2 VAS score
Standard Deviation 0
|
-13.3 VAS score
Standard Deviation 30.75
|
-11.4 VAS score
Standard Deviation 31.11
|
-8.3 VAS score
Standard Deviation 30.62
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
blurred vision_baseline
|
71 VAS score
Standard Deviation 38.37
|
85.7 VAS score
Standard Deviation 14.74
|
93.5 VAS score
Standard Deviation 7.9
|
80.2 VAS score
Standard Deviation 25.18
|
83.2 VAS score
Standard Deviation 24.45
|
78.5 VAS score
Standard Deviation 24.68
|
71 VAS score
Standard Deviation 38.37
|
85.7 VAS score
Standard Deviation 14.74
|
93.5 VAS score
Standard Deviation 7.9
|
80.2 VAS score
Standard Deviation 25.18
|
83.2 VAS score
Standard Deviation 24.45
|
78.5 VAS score
Standard Deviation 24.68
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
blurred vision_CFB
|
-25.7 VAS score
Standard Deviation 34.37
|
-25 VAS score
Standard Deviation 32.15
|
-22 VAS score
Standard Deviation 31.11
|
-24.9 VAS score
Standard Deviation 35.33
|
-26.2 VAS score
Standard Deviation 31.58
|
-17.4 VAS score
Standard Deviation 28.55
|
-26.5 VAS score
Standard Deviation 31.18
|
-26.2 VAS score
Standard Deviation 17.93
|
-14 VAS score
Standard Deviation 0
|
-16.5 VAS score
Standard Deviation 38.42
|
-25.7 VAS score
Standard Deviation 34.41
|
-17.4 VAS score
Standard Deviation 27.14
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
photophobia_baseline
|
64.7 VAS score
Standard Deviation 42.9
|
66.6 VAS score
Standard Deviation 29.85
|
30.3 VAS score
Standard Deviation 26.21
|
64.3 VAS score
Standard Deviation 32.07
|
57.6 VAS score
Standard Deviation 36.1
|
65.2 VAS score
Standard Deviation 34.71
|
64.7 VAS score
Standard Deviation 42.9
|
66.6 VAS score
Standard Deviation 29.85
|
30.3 VAS score
Standard Deviation 26.21
|
64.3 VAS score
Standard Deviation 32.07
|
57.6 VAS score
Standard Deviation 36.1
|
65.2 VAS score
Standard Deviation 34.71
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
photophobia_CFB
|
-19.5 VAS score
Standard Deviation 27.98
|
-20.7 VAS score
Standard Deviation 34.13
|
-30.5 VAS score
Standard Deviation 43.13
|
-17.8 VAS score
Standard Deviation 41.23
|
-13.2 VAS score
Standard Deviation 40.44
|
-17.5 VAS score
Standard Deviation 29.02
|
-20.3 VAS score
Standard Deviation 28.63
|
-26 VAS score
Standard Deviation 39.88
|
-61 VAS score
Standard Deviation 0
|
-24.2 VAS score
Standard Deviation 37.51
|
-21 VAS score
Standard Deviation 38.76
|
-14.6 VAS score
Standard Deviation 29.19
|
SECONDARY outcome
Timeframe: at baseline and at period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20)Population: Safety population
Best-Corrected Distance Visual Acuity (BCDVA) by means of the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart at 4 meters (13 feet). Data reported refers to week n° 8 (treatment group) and n°12/20 (FU group).
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
n=6 Participants
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
n=6 Participants
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
n=2 Participants
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
n=45 Participants
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
n=39 Participants
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
n=48 Participants
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)
Baseline
|
42 Number of ETDRS letters
Standard Deviation 28.25
|
30.4 Number of ETDRS letters
Standard Deviation 24.85
|
9.5 Number of ETDRS letters
Standard Deviation 11.96
|
30.7 Number of ETDRS letters
Standard Deviation 28.35
|
24.2 Number of ETDRS letters
Standard Deviation 25.88
|
32.4 Number of ETDRS letters
Standard Deviation 26.07
|
42 Number of ETDRS letters
Standard Deviation 28.25
|
30.4 Number of ETDRS letters
Standard Deviation 24.85
|
9.5 Number of ETDRS letters
Standard Deviation 11.96
|
30.7 Number of ETDRS letters
Standard Deviation 28.35
|
24.2 Number of ETDRS letters
Standard Deviation 25.88
|
32.4 Number of ETDRS letters
Standard Deviation 26.07
|
|
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)
Change from baseline
|
9.3 Number of ETDRS letters
Standard Deviation 5.89
|
8.7 Number of ETDRS letters
Standard Deviation 12.41
|
-1 Number of ETDRS letters
Standard Deviation 1.41
|
15.8 Number of ETDRS letters
Standard Deviation 16.82
|
11.9 Number of ETDRS letters
Standard Deviation 20.9
|
6.9 Number of ETDRS letters
Standard Deviation 15.44
|
11.2 Number of ETDRS letters
Standard Deviation 7.47
|
7 Number of ETDRS letters
Standard Deviation 9.8
|
-6 Number of ETDRS letters
Standard Deviation 0
|
13.2 Number of ETDRS letters
Standard Deviation 16.8
|
14.2 Number of ETDRS letters
Standard Deviation 19.6
|
8.8 Number of ETDRS letters
Standard Deviation 14.27
|
SECONDARY outcome
Timeframe: Baseline, period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20).Population: safety population
IOP was measured using a Goldmann applanation tonometer, a handheld applanation tonometer \[eg, Tonopen\], or other tonometer, after the instillation of a topical anesthetic.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
n=6 Participants
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
n=6 Participants
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
n=2 Participants
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
n=45 Participants
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
n=39 Participants
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
n=48 Participants
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP)
Baseline
|
16.1 mmHg
Standard Deviation 3.85
|
11.3 mmHg
Standard Deviation 3.68
|
11.8 mmHg
Standard Deviation 3.3
|
14.3 mmHg
Standard Deviation 3.16
|
14 mmHg
Standard Deviation 3.06
|
14.1 mmHg
Standard Deviation 3.16
|
16.1 mmHg
Standard Deviation 3.85
|
11.3 mmHg
Standard Deviation 3.68
|
11.8 mmHg
Standard Deviation 3.3
|
14.3 mmHg
Standard Deviation 3.16
|
14 mmHg
Standard Deviation 3.06
|
14.1 mmHg
Standard Deviation 3.16
|
|
Change From Baseline in Intraocular Pressure (IOP)
Change from baseline
|
-1.8 mmHg
Standard Deviation 2.48
|
1.9 mmHg
Standard Deviation 5.24
|
3.5 mmHg
Standard Deviation 2.12
|
-0.1 mmHg
Standard Deviation 3.71
|
0.9 mmHg
Standard Deviation 2.61
|
0.8 mmHg
Standard Deviation 3.43
|
-2.2 mmHg
Standard Deviation 2.49
|
2.3 mmHg
Standard Deviation 3.78
|
-3 mmHg
Standard Deviation 0
|
0.2 mmHg
Standard Deviation 3.25
|
0.1 mmHg
Standard Deviation 3.64
|
0.6 mmHg
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: At week 8 (Phase 1 and Phase 2)Population: safety population
Dilated fundus ophthalmoscopy was performed to assess the vitreous, retina, macula, choroid and optic nerve head after dilation of the pupil. Percentage of patients is summarized for each eye structure by treatment and visit for the controlled treatment period for Phase I and Phase II separately. The assessment time points were Baseline, weeks 2, 4 and 8 for Phase 1; Baseline and week 8 for Phase 2; and weeks 12 and 56 for follow up. Only results for eye structure at week 8 are reported.
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy
Retina macula
|
25 percentage of participants
|
25 percentage of participants
|
100 percentage of participants
|
17.6 percentage of participants
|
23.3 percentage of participants
|
28.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy
Vitreous
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.7 percentage of participants
|
18.2 percentage of participants
|
10.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy
Choroid
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
8.8 percentage of participants
|
6.5 percentage of participants
|
14.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy
Optic nerve
|
25 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
11.8 percentage of participants
|
12.5 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4, 6 and 8 weeksPopulation: ITT population
Percentage of patients that achieved a ≥15 letter gain in best corrected distance visual acuity (BCDVA) at 4, 6, and 8 weeks
Outcome measures
| Measure |
4_rhNGF10_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=7 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=4 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
|
4_rhNGF10_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
rhNGF 10 μg/ml: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
|
5_rhNGF20_Phase 2_treatment
n=52 Participants
active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
rhNGF 20 μg/ml: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
|
6_vehicle group_Phase 2_treatment
n=52 Participants
vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
vehicle: ophthalmic solution of the same composition as the test product without rhNGF
|
1_rhNGF10_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 10 μg/ml
|
2_rhNGF20_Phase 1_FU
Follow up for Phase 1 active treatment with rhNGF 20 μg/ml
|
3_vehicle group_Phase 1_FU
Follow up for Phase 1 vehicle control arm
|
4_rhNGF10_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 10 μg/ml
|
5_rhNGF20_Phase 2_FU
Follow up for Phase 2 active treatment with rhNGF 20 μg/ml
|
6_vehicle_Phase 2_FU
Follow up for Phase 2 vehicle control arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
week 4 - yes
|
0 percentage of subjects
|
29 percentage of subjects
|
0 percentage of subjects
|
37 percentage of subjects
|
34 percentage of subjects
|
21 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
week 4 - no
|
100 percentage of subjects
|
71 percentage of subjects
|
100 percentage of subjects
|
63 percentage of subjects
|
66 percentage of subjects
|
79 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
week 6 - yes
|
17 percentage of subjects
|
43 percentage of subjects
|
0 percentage of subjects
|
44 percentage of subjects
|
38 percentage of subjects
|
28 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
week 6 - no
|
83 percentage of subjects
|
57 percentage of subjects
|
100 percentage of subjects
|
56 percentage of subjects
|
62 percentage of subjects
|
72 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
week 8 -yes
|
17 percentage of subjects
|
43 percentage of subjects
|
0 percentage of subjects
|
50 percentage of subjects
|
42 percentage of subjects
|
22 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
week 8 - no
|
83 percentage of subjects
|
57 percentage of subjects
|
100 percentage of subjects
|
50 percentage of subjects
|
58 percentage of subjects
|
78 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
1_rhNGF10_Phase 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
2_rhNGF20_Phase 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
3_vehicle group_Phase 1
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
4_rhNGF10_Phase 2_treatment
Serious events: 13 serious events
Other events: 23 other events
Deaths: 5 deaths
5_rhNGF20_Phase 2_treatment
Serious events: 14 serious events
Other events: 23 other events
Deaths: 2 deaths
6_vehicle group_Phase 2_treatment
Serious events: 4 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
1_rhNGF10_Phase 1
n=7 participants at risk
rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
2_rhNGF20_Phase 1
n=7 participants at risk
rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
3_vehicle group_Phase 1
n=4 participants at risk
Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
4_rhNGF10_Phase 2_treatment
n=52 participants at risk
rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
5_rhNGF20_Phase 2_treatment
n=52 participants at risk
rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
6_vehicle group_Phase 2_treatment
n=52 participants at risk
Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only.
|
|---|---|---|---|---|---|---|
|
General disorders
disease progression
|
28.6%
2/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
visual acuity reduced
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Immune system disorders
Corneal graft rejection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Impaired healing
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Blood pressure increased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal endotheliitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Neurotrophic keratopathy
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
Other adverse events
| Measure |
1_rhNGF10_Phase 1
n=7 participants at risk
rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
2_rhNGF20_Phase 1
n=7 participants at risk
rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
3_vehicle group_Phase 1
n=4 participants at risk
Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
4_rhNGF10_Phase 2_treatment
n=52 participants at risk
rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
5_rhNGF20_Phase 2_treatment
n=52 participants at risk
rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only
|
6_vehicle group_Phase 2_treatment
n=52 participants at risk
Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Diastolic hypotension
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Immune system disorders
Corneal graft rejection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Disease progression
|
28.6%
2/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 6 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
11.5%
6/52 • Number of events 6 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Instillation site pruritus
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Irritability
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Instillation site pain
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Inflammation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
General disorders
Impaired healing
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Intraocular pressure increased
|
14.3%
1/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Blood pressure increased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Blood creatine increased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Heart rate increased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Investigations
Vital dye staining cornea present
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
headache
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
42.9%
3/7 • Number of events 6 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
13.5%
7/52 • Number of events 7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
9.6%
5/52 • Number of events 7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Visual acuity reduced
|
42.9%
3/7 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
9.6%
5/52 • Number of events 5 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Photophobia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
42.9%
3/7 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Conjunctival hyperaemia
|
14.3%
1/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
9.6%
5/52 • Number of events 5 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal lesion
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Erythema of eyelid
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye irritation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Photopsia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal decompensation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Keratitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 6 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Ocular hyperemia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Blepharitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
11.5%
6/52 • Number of events 6 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Lacrimation decreased
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal deposits
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye discharge
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Asthenopia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal endotheliitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eye allergy
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Lagophthalmos
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Pseudopterygium
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Retinal cyst
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Cataract
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 5 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Eye disorders
Neurotrophic keratopathy
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 3 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Conjunctivitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Keratitis herpetic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Corneal infection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
7.7%
4/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
5.8%
3/52 • Number of events 4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Blister infected
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 2 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Herpes simplex ophtalmic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Herpes zoster ophtalmic
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/7 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/4 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
0.00%
0/52 • Adverse events were collected at each time point of Phase I and Phase II of the study. Phase I: Days 1, 2, Weeks 1, 2, 3, 4, 6, Day 55, Week 8 Phase II: Weeks 1, 2, 3, 4, 6, 8
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov Definitions.
|
Additional Information
Clinical Development & Operations
Dompé farmaceutici s.p.a.
Phone: +39 02 583831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place