Trial Outcomes & Findings for A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration (NCT NCT02087085)
NCT ID: NCT02087085
Last Updated: 2019-04-23
Results Overview
GA lesion area was measured in mm\^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
310 participants
Primary outcome timeframe
Baseline (Day 1) to Month 24
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
400 µg Brimonidine Implant
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless drug delivery system (DDS) applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
156
|
|
Overall Study
COMPLETED
|
34
|
40
|
|
Overall Study
NOT COMPLETED
|
120
|
116
|
Reasons for withdrawal
| Measure |
400 µg Brimonidine Implant
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless drug delivery system (DDS) applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
14
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
87
|
80
|
|
Overall Study
Other Miscellaneous Reasons
|
3
|
4
|
Baseline Characteristics
Modified intent-to-treat (mITT) population included all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF.
Baseline characteristics by cohort
| Measure |
400 µg Brimonidine Implant
n=154 Participants
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
n=156 Participants
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.9 years
STANDARD_DEVIATION 7.89 • n=154 Participants
|
77.0 years
STANDARD_DEVIATION 7.24 • n=156 Participants
|
76.9 years
STANDARD_DEVIATION 7.56 • n=310 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=154 Participants
|
91 Participants
n=156 Participants
|
192 Participants
n=310 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=154 Participants
|
65 Participants
n=156 Participants
|
118 Participants
n=310 Participants
|
|
Race/Ethnicity, Customized
White
|
153 Participants
n=154 Participants
|
156 Participants
n=156 Participants
|
309 Participants
n=310 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=154 Participants
|
0 Participants
n=156 Participants
|
1 Participants
n=310 Participants
|
|
Geographic Atrophy (GA) Lesion Area by Fundus Autofluorescence (FAF)
|
5.1611 millimeters squared (mm^2)
STANDARD_DEVIATION 3.7016 • n=149 Participants • Modified intent-to-treat (mITT) population included all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF.
|
5.4761 millimeters squared (mm^2)
STANDARD_DEVIATION 3.5961 • n=154 Participants • Modified intent-to-treat (mITT) population included all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF.
|
5.3212 millimeters squared (mm^2)
STANDARD_DEVIATION 3.6457 • n=303 Participants • Modified intent-to-treat (mITT) population included all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Month 24Population: Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis at Month 24.
GA lesion area was measured in mm\^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.
Outcome measures
| Measure |
400 µg Brimonidine Implant
n=86 Participants
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
n=90 Participants
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
|
3.1455 mm^2
Standard Error 0.1377
|
3.5044 mm^2
Standard Error 0.1359
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Month 24Population: Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis for this outcome measure at Month 24.
BCVA was measured using an eye chart (ETDRS) and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Outcome measures
| Measure |
400 µg Brimonidine Implant
n=81 Participants
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
n=82 Participants
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
|
-10.9 letters read correctly
Standard Error 1.0
|
-9.7 letters read correctly
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Month 24Population: Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis for this outcome measure at Month 24.
Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Outcome measures
| Measure |
400 µg Brimonidine Implant
n=81 Participants
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
n=82 Participants
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
|
-8.1 letters read correctly
Standard Error 1.0
|
-6.7 letters read correctly
Standard Error 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Month 24Outcome measures
Outcome data not reported
Adverse Events
400 µg Brimonidine Implant
Serious events: 48 serious events
Other events: 79 other events
Deaths: 5 deaths
Sham
Serious events: 37 serious events
Other events: 61 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
400 µg Brimonidine Implant
n=154 participants at risk
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
n=156 participants at risk
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
3/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
3/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Bradycardia
|
1.9%
3/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
3/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Retinal tear
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Retinal vein occlusion
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Anterior capsule contraction
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
General disorders
Hernia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.9%
3/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.9%
3/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Septic shock
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Flail chest
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Acquired claw toe
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.3%
2/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoplastic melanoma
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal melanoma
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Brain stem ischaemia
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Product Issues
Device dislocation
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
1.3%
2/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Vascular disorders
Hypotension
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Vascular disorders
Varicose vein
|
0.65%
1/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
Other adverse events
| Measure |
400 µg Brimonidine Implant
n=154 participants at risk
400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
|
Sham
n=156 participants at risk
Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
5.2%
8/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
7.1%
11/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Headache
|
5.2%
8/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
2.6%
4/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Vitreous floaters
|
18.8%
29/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
13.6%
21/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
7.1%
11/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Visual impairment
|
7.8%
12/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
3.8%
6/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Eye pain
|
7.1%
11/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
5.8%
9/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
5.8%
9/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
3.8%
6/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Dry eye
|
5.2%
8/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
3.8%
6/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Eye disorders
Ocular discomfort
|
5.2%
8/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
0.64%
1/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
12/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
7.7%
12/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
3/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
9.6%
15/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
5/154 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
6.4%
10/156 • From first dose of study drug to date of last visit (up to approximately 33 months)
Safety population included all participants who received at least 1 administration of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER