Trial Outcomes & Findings for Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK (NCT NCT02227147)
NCT ID: NCT02227147
Last Updated: 2022-12-08
Results Overview
Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Week 8
Results posted on
2022-12-08
Participant Flow
Recruitment was competitive among the study sites, until the planned number of patients were randomized. Competitive recruitment was chosen to increase the speed of recruitment and to account for any difference in enrolment rate among study sites.
Participant milestones
| Measure |
rhNGF 20 µg/ml
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Controlled Treatment Period
STARTED
|
24
|
24
|
|
Controlled Treatment Period
COMPLETED
|
18
|
21
|
|
Controlled Treatment Period
NOT COMPLETED
|
6
|
3
|
|
Follow-up Period
STARTED
|
18
|
21
|
|
Follow-up Period
COMPLETED
|
15
|
16
|
|
Follow-up Period
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
rhNGF 20 µg/ml
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Controlled Treatment Period
Adverse Event
|
4
|
3
|
|
Controlled Treatment Period
Other
|
2
|
0
|
|
Follow-up Period
Other
|
3
|
5
|
Baseline Characteristics
Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK
Baseline characteristics by cohort
| Measure |
rhNGF 20 µg/ml
n=24 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 13.85 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 14.15 • n=107 Participants
|
65.2 years
STANDARD_DEVIATION 13.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: ITT population, LOCF. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.
Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=23 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reviewer
Not completely healed
|
30 percentage of participants
|
71 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reviewer
Completely healed
|
70 percentage of participants
|
29 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT population, LOCF. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.
Percentage of patients experiencing complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as measured by the investigator.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=23 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by the Investigator
Completely healed
|
65 percentage of participants
|
29 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by the Investigator
Not completely healed
|
35 percentage of participants
|
71 percentage of participants
|
SECONDARY outcome
Timeframe: At weeks 4 and 6Population: LOCF, ITT population. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.
Percentage of patients experiencing complete healing of the PED or corneal ulcer at 4, and 6 weeks as measured by the central reading center evaluating the clinical pictures and investigator.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=23 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 4 - central reviewer - yes
|
56 percentage of participants
|
38 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 4 - central reviewer - no
|
44 percentage of participants
|
62 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 6 - central reviewer - yes
|
56 percentage of participants
|
46 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 6 - central reviewer - no
|
44 percentage of participants
|
54 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 4 - investigator - yes
|
56 percentage of participants
|
42 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 4 - investigator - no
|
44 percentage of participants
|
58 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 6 - investigator - yes
|
65 percentage of participants
|
42 percentage of participants
|
|
Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Week 6 - investigator - no
|
35 percentage of participants
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: at weeks 4, 6, and 8Population: LOCF, ITT population. Two patients (randomized to rhNGF although not eligible) had no post-baseline data, were assumed to be missing, and were excluded from the analyses.
Percentage of patients with complete corneal clearing at weeks 4, 6, and 8 defined as grade 0 on the modified Oxford scale. Grade 0 indicates the absence of conjunctival staining; grade V indicates severe conjunctival staining.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=22 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Percentage of Patients With Complete Corneal Clearing
Week 4 - yes
|
14 percentage of participants
|
4 percentage of participants
|
|
Percentage of Patients With Complete Corneal Clearing
Week 4 - no
|
86 percentage of participants
|
96 percentage of participants
|
|
Percentage of Patients With Complete Corneal Clearing
Week 6 - yes
|
9 percentage of participants
|
8 percentage of participants
|
|
Percentage of Patients With Complete Corneal Clearing
Week 6 - no
|
91 percentage of participants
|
92 percentage of participants
|
|
Percentage of Patients With Complete Corneal Clearing
Week 8 - yes
|
23 percentage of participants
|
4 percentage of participants
|
|
Percentage of Patients With Complete Corneal Clearing
Week 8 - no
|
77 percentage of participants
|
96 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: LOCF, ITT Population
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8. Best Corrected Distance Visual Acuity consists of letters read at 4m only.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=23 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)
|
4.48 letters read correctly
Standard Deviation 9.25
|
4.33 letters read correctly
Standard Deviation 10.399
|
SECONDARY outcome
Timeframe: Weeks 4, week 6 and week 8Population: LOCF, ITT population
Percentage of patients that achieve a 15 letter gain in Best Corrected Distance Visual Acuity (BCDVA) at 4 weeks, 6 weeks, 8 weeks
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=24 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
week 8 - no
|
87 percentage of subjects
|
83 percentage of subjects
|
|
Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
week 4 - yes
|
9 percentage of subjects
|
12 percentage of subjects
|
|
Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
week 4 - no
|
91 percentage of subjects
|
88 percentage of subjects
|
|
Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
week 6 - yes
|
13 percentage of subjects
|
12 percentage of subjects
|
|
Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
week 6 - no
|
87 percentage of subjects
|
88 percentage of subjects
|
|
Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
week 8 -yes
|
13 percentage of subjects
|
17 percentage of subjects
|
SECONDARY outcome
Timeframe: At 4, 6 and 8 weeks after start of the treatmentPopulation: ITT population
Improvement in corneal sensitivity was measured by the Cochet-Bonnet aesthesiometer at 4, 6 and 8 weeks. Corneal sensitivity is measured continuously in each patient in cm: * Area of the Persistent Epithelial Defect (PED) or corneal ulcer * All quadrants, but outside the PED or corneal ulcer area: Superior nasal, inferior nasal, superior temporal, inferior temporal. Improvement is defined as an increase of at least 0.5 cm in the location of concern.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=24 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=24 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Improvement in Corneal Sensitivity
week 4
|
2.50 cm
Standard Deviation 1.821
|
1.56 cm
Standard Deviation 1.983
|
|
Improvement in Corneal Sensitivity
week 6
|
2.26 cm
Standard Deviation 2.009
|
1.84 cm
Standard Deviation 2.150
|
|
Improvement in Corneal Sensitivity
week 8
|
2.91 cm
Standard Deviation 2.144
|
1.83 cm
Standard Deviation 1.952
|
|
Improvement in Corneal Sensitivity
Change from baseline to week 8
|
1.88 cm
Standard Deviation 1.401
|
1.00 cm
Standard Deviation 1.254
|
SECONDARY outcome
Timeframe: from baseline to Week 8.Population: ITT population. As far as this endpoint is concerned, data are available (non-missing) for 18 patients out of 24 in the rhNGF group, and for 15 patients out of 24 for the vehicle group.
Number of patients experiencing deterioration (increase in lesion size ≥ 1mm and/or decrease in BCDVA by \>5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and/or progression in lesion depth to corneal melting or perforation and/or onset of infection) in stage 2 or 3 NK from baseline to Week 8.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=18 Participants
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle
n=15 Participants
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
|---|---|---|
|
Patients Experiencing Deterioration
Deterioration
|
0 Number of subjects
|
2 Number of subjects
|
|
Patients Experiencing Deterioration
No deterioration
|
18 Number of subjects
|
13 Number of subjects
|
Adverse Events
rhNGF 20 µg/ml - Controlled Treatment Period
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Vehicle - Controlled Treatment Period
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
rhNGF 20 µg/ml - Follow-up Period
Serious events: 4 serious events
Other events: 14 other events
Deaths: 5 deaths
Vehicle - Follow-up Period
Serious events: 2 serious events
Other events: 9 other events
Deaths: 2 deaths
Uncontrolled Treatment Period
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhNGF 20 µg/ml - Controlled Treatment Period
n=23 participants at risk
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle - Controlled Treatment Period
n=24 participants at risk
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
rhNGF 20 µg/ml - Follow-up Period
n=14 participants at risk；n=18 participants at risk
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle - Follow-up Period
n=9 participants at risk；n=21 participants at risk
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
Uncontrolled Treatment Period
n=13 participants at risk
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
Patients randomized to vehicle at baseline and not completely healed at week 8 who entered a 8-week treatment period before entering follow-up period
|
|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/18 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal Thinning
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/18 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Injury, poisoning and procedural complications
Aqueous Humour Leakage
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/18 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Disease Progression
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/18 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
decreased visual acuity
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
5.6%
1/18 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.8%
1/21 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Gastrointestinal disorders
ventral hernia
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/18 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal perforation
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
2/18 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Death
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
5.6%
1/18 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Disease recurrence
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/18 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.8%
1/21 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Viral gastroenteritis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
5.6%
1/18 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/21 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
—
0/0 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
Other adverse events
| Measure |
rhNGF 20 µg/ml - Controlled Treatment Period
n=23 participants at risk
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle - Controlled Treatment Period
n=24 participants at risk
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
rhNGF 20 µg/ml - Follow-up Period
n=14 participants at risk；n=18 participants at risk
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
rhNGF 20µg/ml
|
Vehicle - Follow-up Period
n=9 participants at risk；n=21 participants at risk
vehicle, formulation containing anti-oxidant
Placebo Vehicle
|
Uncontrolled Treatment Period
n=13 participants at risk
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
Patients randomized to vehicle at baseline and not completely healed at week 8 who entered a 8-week treatment period before entering follow-up period
|
|---|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
21.7%
5/23 • Number of events 5 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
20.8%
5/24 • Number of events 7 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
22.2%
2/9 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
15.4%
2/13 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eye pain
|
30.4%
7/23 • Number of events 11 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
21.4%
3/14 • Number of events 3 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
22.2%
2/9 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
15.4%
2/13 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal Epithelium Defect
|
13.0%
3/23 • Number of events 3 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
14.3%
2/14 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eye Inflammation
|
13.0%
3/23 • Number of events 3 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Lacrimation Increased
|
17.4%
4/23 • Number of events 4 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
14.3%
2/14 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Ocular Hyperaemia
|
17.4%
4/23 • Number of events 4 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
22.2%
2/9 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal Thinning
|
8.7%
2/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eye Irritation
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
16.7%
4/24 • Number of events 5 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Ocular Discomfort
|
8.7%
2/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Photophobia
|
8.7%
2/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Cataract
|
13.0%
3/23 • Number of events 3 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Foreign Body Sensation In Eyes
|
8.7%
2/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Posterior Capsule Opacification
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Anterior Chamber Inflammation
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Conjunctivitis Allergic
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal Deposits
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal Neovascularisation
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal Perforation
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eye Discharge
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eye Swelling
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eyelid Oedema
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Eyelid Pain
|
4.3%
1/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Hyphaema
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Iritis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Keratitis
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Macular Fibrosis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Meibomian Gland Dysfunction
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Trichiasis
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Ulcerative Keratitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Vision Blurred
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Vitreous Floaters
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Disease Progression
|
8.7%
2/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
16.7%
4/24 • Number of events 4 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Sensation Of Foreign Body
|
8.7%
2/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Chest Pain
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Eye Infection Intraocular
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Hordeolum
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Ophthalmic Herpes Zoster
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Nervous system disorders
Diabetic Neuropathy
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Nervous system disorders
Paraesthesia
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Nervous system disorders
Syncope
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Investigations
Intraocular Pressure Increased
|
13.0%
3/23 • Number of events 4 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
8.3%
2/24 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
14.3%
2/14 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Injury, poisoning and procedural complications
Animal Bite
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Injury, poisoning and procedural complications
Aqueous Humour Leakage
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
4.3%
1/23 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
4.2%
1/24 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Blepharitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Chalazion
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Conjunctivochalasis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Corneal opacity
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Dry eye
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Eye disorders
Floppy eyelid syndrome
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
22.2%
2/9 • Number of events 2 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Disease progression
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
General disorders
Sensation of foreign body
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Ear and labyrinth disorders
motion sickness
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
11.1%
1/9 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Nervous system disorders
Migrane
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.1%
1/14 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/13 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/23 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/24 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/14 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
0.00%
0/9 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
7.7%
1/13 • Number of events 1 • Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study: * 23 patients: rhNGF during the Controlled Treatment Period * 24 patients: vehicle during the Controlled Treatment Period * 18 patients: rhNGF during the Follow-up Period * 21 patients: vehicle during the Follow-up Period * 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place