Trial Outcomes & Findings for A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) (NCT NCT05376176)
NCT ID: NCT05376176
Last Updated: 2026-08-07
Results Overview
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Results posted on
2026-08-07
Participant Flow
Participant milestones
| Measure |
STN1010904 Ophthalmic Suspension 0.03% BID
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
Placebo Vehicle BID
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)
Baseline characteristics by cohort
| Measure |
STN1010904 Ophthalmic Suspension 0.03% BID
n=32 Participants
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
n=32 Participants
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
Placebo Vehicle BID
n=22 Participants
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
21 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
58 Participants
n=6 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
45 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
41 Participants
n=6 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 10.96 • n=20 Participants
|
64.0 years
STANDARD_DEVIATION 7.88 • n=20 Participants
|
62.9 years
STANDARD_DEVIATION 9.73 • n=40 Participants
|
62.5 years
STANDARD_DEVIATION 9.58 • n=6 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
53 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=20 Participants
|
21 participants
n=20 Participants
|
14 participants
n=40 Participants
|
57 participants
n=6 Participants
|
|
Region of Enrollment
France
|
6 participants
n=20 Participants
|
5 participants
n=20 Participants
|
4 participants
n=40 Participants
|
15 participants
n=6 Participants
|
|
Region of Enrollment
India
|
4 participants
n=20 Participants
|
6 participants
n=20 Participants
|
4 participants
n=40 Participants
|
14 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.Population: As the analysis is conducted using the Full Analysis Set, the number of participants does not necessarily correspond to that presented in the Participant Flow.
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Outcome measures
| Measure |
Placebo Vehicle BID
n=22 Participants
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
STN1010904 Ophthalmic Suspension 0.03% BID
n=31 Participants
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
n=29 Participants
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18
|
0.026 LogMAR
Standard Error 0.0203
|
0.039 LogMAR
Standard Error 0.0176
|
0.042 LogMAR
Standard Error 0.0181
|
PRIMARY outcome
Timeframe: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.Population: As the analysis is conducted using the Full Analysis Set, the number of participants does not necessarily correspond to that presented in the Participant Flow.
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 10% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Outcome measures
| Measure |
Placebo Vehicle BID
n=22 Participants
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
STN1010904 Ophthalmic Suspension 0.03% BID
n=31 Participants
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
n=29 Participants
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
|---|---|---|---|
|
Change From Baseline in BCVA With Contrast Level of 10% at Month 18
|
-0.014 LogMAR
Standard Error 0.0336
|
-0.005 LogMAR
Standard Error 0.0294
|
0.085 LogMAR
Standard Error 0.0302
|
PRIMARY outcome
Timeframe: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.Population: As the analysis is conducted using the Full Analysis Set, the number of participants does not necessarily correspond to that presented in the Participant Flow.
This measure evaluates the change in contrast sensitivity under glare conditions from baseline to Month 18. Baseline is defined as the measurement obtained prior to the first dose at Visit 2, or the last available pre-dose measurement if Visit 2 data are unavailable. The change is calculated as the difference between the Month 18 value and the baseline value. AULCSF is calculated using the below steps: Measure contrast sensitivity (CS) at several spatial frequencies (cpd, cycles per degree). For example, at spatial frequencies of 3, 6, 12, 18. Convert the corresponding contrast sensitivity to log10 scale. Convert spatial frequencies to log10 scale. For example, log10(3), log10(6), log10(12), log10(18). Calculate the area using trapezoidal rule. Therefore, the actual measurement of AULCSF is log CS × log(cpd). For simplification, we referred to this as log scale. Higher AULCSF indicates better contrast sensitivity and better visual function.
Outcome measures
| Measure |
Placebo Vehicle BID
n=22 Participants
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
STN1010904 Ophthalmic Suspension 0.03% BID
n=31 Participants
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
n=29 Participants
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
|---|---|---|---|
|
Change From Baseline in Contrast Sensitivity With Glare Light at Month 18
|
0.060 log CS × log(cpd)
Standard Error 0.0479
|
0.078 log CS × log(cpd)
Standard Error 0.0420
|
-0.067 log CS × log(cpd)
Standard Error 0.0434
|
Adverse Events
STN1010904 Ophthalmic Suspension 0.03% BID
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
STN1010904 Ophthalmic Suspension 0.1% BID
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Vehicle BID
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STN1010904 Ophthalmic Suspension 0.03% BID
n=33 participants at risk
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
n=32 participants at risk
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
Placebo Vehicle BID
n=21 participants at risk
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
Other adverse events
| Measure |
STN1010904 Ophthalmic Suspension 0.03% BID
n=33 participants at risk
STN1010904 ophthalmic suspension 0.03% BID: 0.03% STN1010904 ophthalmic suspension BID
|
STN1010904 Ophthalmic Suspension 0.1% BID
n=32 participants at risk
STN1010904 ophthalmic suspension 0.1% BID: 0.1% STN1010904 ophthalmic suspension BID
|
Placebo Vehicle BID
n=21 participants at risk
Placebo (Vehicle) BID: Placebo (vehicle) BID
|
|---|---|---|---|
|
Eye disorders
Corneal oedema
|
15.2%
5/33 • Number of events 7 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
18.8%
6/32 • Number of events 8 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Eye irritation
|
12.1%
4/33 • Number of events 6 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Vision blurred
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Eye pain
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Dry eye
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Foreign body sensation in eyes
|
3.0%
1/33 • Number of events 3 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Eye pruritus
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Photophobia
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Visual impairment
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Blepharitis
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Conjunctival haemorrhage
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Corneal degeneration
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Corneal opacity
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Corneal thickening
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Eyelid cyst
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Periorbital irritation
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Tractional retinal detachment
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Eye disorders
Ulcerative keratitis
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
COVID-19
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
6.2%
2/32 • Number of events 3 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
6.2%
2/32 • Number of events 4 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
General disorders
Pain
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
General disorders
Feeling abnormal
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Nervous system disorders
Burning sensation
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Nervous system disorders
Parkinson's disease
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Cardiac disorders
Angina pectoris
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/32 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/33 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
0.00%
0/21 • Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).
The number of participants at risk in 0.03% STN1010904 arm is greater than the number of participants included in the Participant Flow module due to "assigned treatment" and "actual treatment received" for a participant. The planned (placebo) and actual (0.3% STN1010904) arms were different. Therefore, AE was calculated using actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place