Trial Outcomes & Findings for A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (NCT NCT04607148)
NCT ID: NCT04607148
Last Updated: 2023-10-16
Results Overview
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
From baseline up to Week 104
Results posted on
2023-10-16
Participant Flow
Participant milestones
| Measure |
Galegenimab 10MG Q4W
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
70
|
12
|
48
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
70
|
12
|
48
|
Reasons for withdrawal
| Measure |
Galegenimab 10MG Q4W
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
2
|
8
|
|
Overall Study
Study Terminated by Sponsor
|
14
|
59
|
9
|
39
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
3
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Galegenimab 10MG Q4W
n=14 Participants
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
n=70 Participants
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
n=12 Participants
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
n=48 Participants
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
77.3 Years
STANDARD_DEVIATION 5.4 • n=93 Participants
|
80.2 Years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
78.1 Years
STANDARD_DEVIATION 6.9 • n=27 Participants
|
78.8 Years
STANDARD_DEVIATION 8.5 • n=483 Participants
|
79.3 Years
STANDARD_DEVIATION 7.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
86 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
58 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
140 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
143 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From baseline up to Week 104Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Outcome measures
| Measure |
Galegenimab 10MG Q4W
n=14 Participants
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
n=70 Participants
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
n=12 Participants
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
n=48 Participants
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|---|---|---|---|---|
|
Percentage of Participants With Ocular Adverse Events
|
50 Percentage of Participants
|
42.9 Percentage of Participants
|
25 Percentage of Participants
|
27.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 104Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
Outcome measures
| Measure |
Galegenimab 10MG Q4W
n=14 Participants
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
n=70 Participants
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
n=12 Participants
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
n=48 Participants
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|---|---|---|---|---|
|
Percentage of Participants With Systemic (Non-Ocular) Adverse Events
|
71.4 Percentage of Participants
|
70 Percentage of Participants
|
33.3 Percentage of Participants
|
47.9 Percentage of Participants
|
Adverse Events
Galegenimab 10MG Q4W
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Galegenimab 20MG Q4W
Serious events: 13 serious events
Other events: 26 other events
Deaths: 3 deaths
Galegenimab 10MG Q8W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Galegenimab 20MG Q8W
Serious events: 10 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Galegenimab 10MG Q4W
n=14 participants at risk
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
n=70 participants at risk
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
n=12 participants at risk
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
n=48 participants at risk
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 3 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Blindness cortical
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Optic neuropathy
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal artery spasm
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Uveitis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitritis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.3%
3/70 • Number of events 6 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.2%
2/48 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Gastric operation
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Galegenimab 10MG Q4W
n=14 participants at risk
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
|
Galegenimab 20MG Q4W
n=70 participants at risk
Participants will receive 20 mg galegenimab via ITV injection Q4W.
|
Galegenimab 10MG Q8W
n=12 participants at risk
Participants will receive 10 mg galegenimab via ITV injection Q8W.
|
Galegenimab 20MG Q8W
n=48 participants at risk
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.6%
6/70 • Number of events 7 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Iridocyclitis
|
21.4%
3/14 • Number of events 3 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Iritis
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Periorbital pain
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
5.7%
4/70 • Number of events 4 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal haemorrhage
|
14.3%
2/14 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.2%
2/48 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
21.4%
3/14 • Number of events 3 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
5.7%
4/70 • Number of events 6 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitritis
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
14.3%
2/14 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
14.3%
2/14 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
11.4%
8/70 • Number of events 8 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.2%
2/48 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal foot infection
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 3 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
6.2%
3/48 • Number of events 3 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
1/70 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.9%
2/70 • Number of events 2 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
6.2%
3/48 • Number of events 4 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
7.1%
1/14 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
5.7%
4/70 • Number of events 4 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/14 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/70 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/48 • From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER