Trial Outcomes & Findings for Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy (NCT NCT05536297)
NCT ID: NCT05536297
Last Updated: 2026-05-18
Results Overview
An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment. AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre-existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
278 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2026-05-18
Participant Flow
Participants who completed study ISEE2008 (NCT04435366; GATHER2) through the Month 23 visit on assigned treatment (avacincaptad pegol \[ACP\] or sham) were enrolled in the study.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.
Participant milestones
| Measure |
ACP Every Month (EM) to ACP EM
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACP EM/Every Other Month (EOM) to ACP EM
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
62
|
152
|
|
Overall Study
COMPLETED
|
56
|
54
|
127
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
25
|
Reasons for withdrawal
| Measure |
ACP Every Month (EM) to ACP EM
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACP EM/Every Other Month (EOM) to ACP EM
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
7
|
|
Overall Study
Other
|
1
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Participant Request
|
5
|
2
|
10
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
2
|
|
Overall Study
Investigator Decision
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
Baseline Characteristics
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
Baseline characteristics by cohort
| Measure |
ACP EM to ACP EM
n=64 Participants
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACP EM/EOM to ACP EM
n=62 Participants
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
n=152 Participants
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 9.3 • n=11 Participants
|
78.6 years
STANDARD_DEVIATION 8.1 • n=9 Participants
|
77.9 years
STANDARD_DEVIATION 8.4 • n=20 Participants
|
77.6 years
STANDARD_DEVIATION 8.6 • n=78 Participants
|
|
Age, Customized
In Utero
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Age, Customized
Pre-term newborn - gestational age < 37 wk
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Age, Customized
Adults (18-64 years)
|
9 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
11 Participants
n=20 Participants
|
23 Participants
n=78 Participants
|
|
Age, Customized
Elderly (From 65-84 years)
|
44 Participants
n=11 Participants
|
41 Participants
n=9 Participants
|
108 Participants
n=20 Participants
|
193 Participants
n=78 Participants
|
|
Age, Customized
Elderly 85 years and over
|
11 Participants
n=11 Participants
|
18 Participants
n=9 Participants
|
33 Participants
n=20 Participants
|
62 Participants
n=78 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=11 Participants
|
38 Participants
n=9 Participants
|
105 Participants
n=20 Participants
|
189 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=11 Participants
|
24 Participants
n=9 Participants
|
47 Participants
n=20 Participants
|
89 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
16 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=11 Participants
|
45 Participants
n=9 Participants
|
126 Participants
n=20 Participants
|
223 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=11 Participants
|
13 Participants
n=9 Participants
|
19 Participants
n=20 Participants
|
39 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=11 Participants
|
47 Participants
n=9 Participants
|
130 Participants
n=20 Participants
|
234 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
7 Participants
n=11 Participants
|
13 Participants
n=9 Participants
|
19 Participants
n=20 Participants
|
39 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Safety Analysis Set included all participants who were administered at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment. AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre-existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.
Outcome measures
| Measure |
ACP EM to ACP EM
n=64 Participants
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACP EM/EOM to ACP EM
n=61 Participants
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
n=151 Participants
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
50 Participants
|
49 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Anti-drug Antibody Analysis Set included all treated participants with at least 1 valid anti-drug antibody result.
Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample. For participants whose ADA status is positive at Baseline, a post-baseline titer value that is \>= 4 times higher than the Baseline is considered treatment-boosted ADA.
Outcome measures
| Measure |
ACP EM to ACP EM
n=63 Participants
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACP EM/EOM to ACP EM
n=60 Participants
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
n=145 Participants
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Number of Participants With Anti-drug Antibody (ADA)
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Months 1, 2, 4, 7, 13, and 18Population: Pharmacokinetic Analysis Set included all treated participants with at least 1 valid plasma concentrations result.
Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics.
Outcome measures
| Measure |
ACP EM to ACP EM
n=64 Participants
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACP EM/EOM to ACP EM
n=61 Participants
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
n=151 Participants
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Plasma Concentrations of ACP
Month 13
|
44.8 ng/mL
Standard Deviation 29.8
|
34.4 ng/mL
Standard Deviation 29.4
|
36.0 ng/mL
Standard Deviation 29.3
|
|
Plasma Concentrations of ACP
Month 18
|
42.3 ng/mL
Standard Deviation 33.7
|
38.7 ng/mL
Standard Deviation 30.2
|
33.9 ng/mL
Standard Deviation 30.1
|
|
Plasma Concentrations of ACP
Month 7
|
33.7 ng/mL
Standard Deviation 27.3
|
30.0 ng/mL
Standard Deviation 23.1
|
37.5 ng/mL
Standard Deviation 30.8
|
|
Plasma Concentrations of ACP
Month 1
|
9.17 ng/mL
Standard Deviation 20.9
|
5.97 ng/mL
Standard Deviation 13.9
|
0.0440 ng/mL
Standard Deviation 0.537
|
|
Plasma Concentrations of ACP
Month 2
|
35.6 ng/mL
Standard Deviation 21.8
|
31.7 ng/mL
Standard Deviation 24.4
|
31.9 ng/mL
Standard Deviation 19.3
|
|
Plasma Concentrations of ACP
Month 4
|
41.1 ng/mL
Standard Deviation 28.3
|
37.8 ng/mL
Standard Deviation 38.3
|
34.6 ng/mL
Standard Deviation 23.3
|
Adverse Events
ACP EM to ACP EM
Serious events: 14 serious events
Other events: 42 other events
Deaths: 0 deaths
ACPEM/EOM to ACP EM
Serious events: 13 serious events
Other events: 39 other events
Deaths: 2 deaths
Sham to ACP EM
Serious events: 24 serious events
Other events: 93 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ACP EM to ACP EM
n=64 participants at risk
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACPEM/EOM to ACP EM
n=61 participants at risk
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
n=151 participants at risk
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.3%
2/151 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Dry age-related macular degeneration
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Optic ischaemic neuropathy
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.3%
2/151 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.3%
2/151 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cauda equina
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Pancreatogenous diabetes
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.3%
2/151 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/151 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.3%
2/151 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Surgical and medical procedures
Vascular graft
|
0.00%
0/64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.00%
0/61 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
0.66%
1/151 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
Other adverse events
| Measure |
ACP EM to ACP EM
n=64 participants at risk
All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
ACPEM/EOM to ACP EM
n=61 participants at risk
All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
Sham to ACP EM
n=151 participants at risk
All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
|
|---|---|---|---|
|
Eye disorders
Posterior capsule opacification
|
1.6%
1/64 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
4.9%
3/61 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
5.3%
8/151 • Number of events 8 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Punctate keratitis
|
3.1%
2/64 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
6.0%
9/151 • Number of events 9 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
6.2%
4/64 • Number of events 5 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
4.9%
3/61 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
11.9%
18/151 • Number of events 23 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Vitreous detachment
|
6.2%
4/64 • Number of events 4 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
2.0%
3/151 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.1%
2/64 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
2.0%
3/151 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
12.5%
8/64 • Number of events 8 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 5 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
6.0%
9/151 • Number of events 9 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
3.1%
2/64 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
5.3%
8/151 • Number of events 8 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
4/64 • Number of events 4 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
6.0%
9/151 • Number of events 10 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
5/64 • Number of events 6 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
7.3%
11/151 • Number of events 13 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
14.1%
9/64 • Number of events 9 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 7 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
7.9%
12/151 • Number of events 14 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
14.1%
9/64 • Number of events 13 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
16.4%
10/61 • Number of events 18 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
13.9%
21/151 • Number of events 54 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
4/64 • Number of events 4 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
1.3%
2/151 • Number of events 2 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
9.4%
6/64 • Number of events 10 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
16.4%
10/61 • Number of events 17 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
9.3%
14/151 • Number of events 17 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Choroidal neovascularisation
|
15.6%
10/64 • Number of events 11 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
4.9%
3/61 • Number of events 3 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
13.2%
20/151 • Number of events 23 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
10.9%
7/64 • Number of events 26 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
9.8%
6/61 • Number of events 34 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
11.3%
17/151 • Number of events 64 • All-cause mortality: From randomization up to 18 months. AEs: From first dose of study drug up to 18 months.
All-cause mortality: FAS included all enrolled participants. AEs: Safety Analysis Set included all enrolled participants who had at least 1 dose of study drug.
|
Additional Information
Clinical Transparency
Astellas Pharma Global Development, Inc
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PIs are not employed by the Sponsor. An agreement between PIs and the Sponsor (or its agents) restricts the PI's rights to discuss or publish trial results after the trial is completed. The institute and/or PI may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER