Trial Outcomes & Findings for Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration (NCT NCT01367444)
NCT ID: NCT01367444
Last Updated: 2022-04-14
Results Overview
An adverse event (AE) was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the investigational product. The TEAEs were defined as any event that started or increased in severity after the participant received investigational medicinal product (IMP), including abnormal laboratory results, electrocardiogram, etc.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
From Baseline to Week 48
Results posted on
2022-04-14
Participant Flow
The Study was conducted in France and the United States. The trial was ended prematurely and the end of trial date declaration to health authorities was 16-August-2019.
A total of 35 participants who had Stargardt's Macular Degeneration (SMD) were screened, out of which 27 participants were enrolled in 7 cohorts (Cohorts 1 to 7).
Participant milestones
| Measure |
Cohort 1
Participants (aged greater than or equal to \[\>=\] 18 years) with advanced SMD, and visual acuity (VA) less than or equal to (\<=) 20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field electroretinography (ERG) responses, received SAR422459 at lowest target dose level 1.8\*10\^5 transducing units (TU)/study eye.
|
Cohort 2
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 3
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6\*10\^5 TU/study eye.
|
Cohort 4
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 5
Participants (aged \>=18 years) with SMD, and VA \<=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 6
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA \>=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 7
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA \>=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
6
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
6
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration
Baseline characteristics by cohort
| Measure |
Cohort 1
n=4 Participants
Participants (aged \>=18 years) with advanced SMD, and VA \<=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 2
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 3
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6\*10\^5 TU/study eye.
|
Cohort 4
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 5
n=6 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 6
n=4 Participants
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA \>=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 7
n=1 Participants
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA \>=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
40 years
n=7 Participants
|
44.5 years
n=5 Participants
|
40 years
n=4 Participants
|
28 years
n=21 Participants
|
23 years
n=8 Participants
|
16 years
n=8 Participants
|
36 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 48Population: Analysis was performed on all participants with SMD who were included in the study.
An adverse event (AE) was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the investigational product. The TEAEs were defined as any event that started or increased in severity after the participant received investigational medicinal product (IMP), including abnormal laboratory results, electrocardiogram, etc.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
Participants (aged \>=18 years) with advanced SMD, and VA \<=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 2
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 3
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6\*10\^5 TU/study eye.
|
Cohort 4
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 5
n=6 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 6
n=4 Participants
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA \>=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 7
n=1 Participants
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA \>=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 48Population: Analysis was performed on all participants with SMD who were included in the study.
An AE was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the investigational product. For each AE, the severity was categorized as either mild, moderate or severe where 'mild' was defined as discomfort noticed but did not interfere with the participant's daily routines (an annoyance), 'moderate' was defined as some impairment of function, not hazardous to health (uncomfortable or embarrassing), and 'severe' was defined as significant impairment of function, hazardous to health (incapacitating).
Outcome measures
| Measure |
Cohort 1
n=4 Participants
Participants (aged \>=18 years) with advanced SMD, and VA \<=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 2
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 3
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6\*10\^5 TU/study eye.
|
Cohort 4
n=4 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 5
n=6 Participants
Participants (aged \>=18 years) with SMD, and VA \<=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 6
n=4 Participants
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA \>=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 7
n=1 Participants
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA \>=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With TEAEs by Severity
Mild
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With TEAEs by Severity
Moderate
|
0 percentage of participants
|
50 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
33 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With TEAEs by Severity
Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25 percentage of participants
|
17 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 6
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 7
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=4 participants at risk
Participants (aged \>=18 years) with advanced SMD, and VA \<=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 2
n=4 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 3
n=4 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6\*10\^5 TU/study eye.
|
Cohort 4
n=4 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 5
n=6 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 6
n=4 participants at risk
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA \>=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 7
n=1 participants at risk
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA \>=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Intraocular pressure increased
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
Other adverse events
| Measure |
Cohort 1
n=4 participants at risk
Participants (aged \>=18 years) with advanced SMD, and VA \<=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 2
n=4 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8\*10\^5 TU/study eye.
|
Cohort 3
n=4 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6\*10\^5 TU/study eye.
|
Cohort 4
n=4 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 5
n=6 participants at risk
Participants (aged \>=18 years) with SMD, and VA \<=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 6
n=4 participants at risk
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA \>=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
Cohort 7
n=1 participants at risk
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA \>=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8\*10\^6 TU/study eye.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Chalazion
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Choroidal effusion
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
75.0%
3/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
3/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Xanthopsia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Dyschromatopsia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eye discharge
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eye disorder
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
33.3%
2/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eye pain
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
33.3%
2/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Keratic precipitates
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Macular oedema
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
33.3%
2/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Necrotising retinitis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Ocular hyperaemia
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Photopsia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Retinal disorder
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Retinal tear
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Serous retinal detachment
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Subretinal fibrosis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Subretinal fluid
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
33.3%
2/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Trichiasis
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Eye disorders
Vitreous floaters
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
33.3%
2/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
General disorders
Asthenia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
General disorders
Pain
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Infections and infestations
Conjunctivitis viral
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Colour vision tests abnormal
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Fundoscopy abnormal
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Intraocular pressure decreased
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
33.3%
2/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Intraocular pressure increased
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
75.0%
3/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Monoclonal immunoglobulin present
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Investigations
Visual field tests abnormal
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
50.0%
2/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
100.0%
1/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
16.7%
1/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
25.0%
1/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/6 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/4 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
0.00%
0/1 • All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Reported AEs were TEAEs that developed/worsened during the 'on treatment period' (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER