Trial Outcomes & Findings for A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy (NCT NCT01940887)
NCT ID: NCT01940887
Last Updated: 2024-10-31
Results Overview
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
645 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-31
Participant Flow
The study was conducted at 214 centers (107 in North America and 107 in the rest of the world) in 22 countries (20 of which enrolled patients) between 19 May 2014 and 15 September 2017.
Three (3) of the 645 patients who were enrolled and randomized did not receive treatments. Remaining 642 subjects were grouped into two treatment groups (E10030 + Eylea/Avastin vs. Sham + Eylea/Avastin) for the purposes of efficacy analyses in accordance with the pre-specified study design, and the SAP.
Participant milestones
| Measure |
E10030 + Bevacizumab or Aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
|
Sham + Bevacizumab or Aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
E10030 sham injection: Pressure on the eye with a syringe with no needle
|
|---|---|---|
|
Year 1
STARTED
|
322
|
320
|
|
Year 1
COMPLETED
|
283
|
297
|
|
Year 1
NOT COMPLETED
|
39
|
23
|
|
Year 2
STARTED
|
283
|
297
|
|
Year 2
COMPLETED
|
66
|
75
|
|
Year 2
NOT COMPLETED
|
217
|
222
|
Reasons for withdrawal
| Measure |
E10030 + Bevacizumab or Aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
|
Sham + Bevacizumab or Aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
E10030 sham injection: Pressure on the eye with a syringe with no needle
|
|---|---|---|
|
Year 1
Protocol Violation
|
0
|
1
|
|
Year 1
Physician Decision
|
7
|
3
|
|
Year 1
Death
|
5
|
3
|
|
Year 1
Adverse Event
|
7
|
6
|
|
Year 1
Withdrawal by Subject
|
18
|
9
|
|
Year 1
Lost to Follow-up
|
2
|
1
|
|
Year 2
Physician Decision
|
8
|
1
|
|
Year 2
Death
|
0
|
2
|
|
Year 2
Sponsor Decision, early termination
|
192
|
203
|
|
Year 2
Adverse Event
|
8
|
2
|
|
Year 2
Withdrawal by Subject
|
8
|
8
|
|
Year 2
Lost to Follow-up
|
1
|
6
|
Baseline Characteristics
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
Baseline characteristics by cohort
| Measure |
E10030 + Bevacizumab or Aflibercept
n=322 Participants
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
|
Sham + Bevacizumab or Aflibercept
n=320 Participants
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
E10030 sham injection: Pressure on the eye with a syringe with no needle
|
Total
n=642 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.5 years
STANDARD_DEVIATION 8.36 • n=99 Participants
|
76.6 years
STANDARD_DEVIATION 8.36 • n=107 Participants
|
76.6 years
STANDARD_DEVIATION 8.36 • n=206 Participants
|
|
Age, Customized
Age · Adults 18-64 years
|
31 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Age, Customized
Age · Adults 65-84 years
|
239 Participants
n=99 Participants
|
239 Participants
n=107 Participants
|
478 Participants
n=206 Participants
|
|
Age, Customized
Age · Adults 85 years and over
|
52 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
370 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
294 Participants
n=99 Participants
|
297 Participants
n=107 Participants
|
591 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Colombia
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
48 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
92 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Latvia
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
32 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Region of Enrollment
Slovakia
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Region of Enrollment
Estonia
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: As pre-specified in the SAP and per the study design, 2 treatment groups (E10030 +Eylea/Avastin vs. Sham + Eylea/Avastin) will be compared. All 642 subjects who received at least one dose of the study drug, irrespective of the dose received, were included in the analysis.
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
Outcome measures
| Measure |
E10030 + Bevacizumab or Aflibercept
n=322 Participants
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
|
Sham + Bevacizumab or Aflibercept
n=320 Participants
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
E10030 sham injection: Pressure on the eye with a syringe with no needle
|
|---|---|---|
|
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
|
9.42 letters
Standard Error 0.85
|
9.04 letters
Standard Error 0.85
|
Adverse Events
E10030 + Bevacizumab or Aflibercept
Serious events: 58 serious events
Other events: 105 other events
Deaths: 7 deaths
Sham + Bevacizumab or Aflibercept
Serious events: 32 serious events
Other events: 107 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
E10030 + Bevacizumab or Aflibercept
n=322 participants at risk
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
|
Sham + Bevacizumab or Aflibercept
n=320 participants at risk
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
E10030 sham injection: Pressure on the eye with a syringe with no needle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
3/322 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
2/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.94%
3/320 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.62%
2/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.94%
3/320 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Autoimmune uveitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Cataract
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Corneal endotheliitis
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Iridocyclitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Macular hole
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Retinal detachment
|
0.31%
1/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Retinal haemorrhage
|
0.62%
2/322 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Gastric dysplasia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.62%
2/320 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Gastrointestinal disorders
Melaena
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
General disorders
Device dislocation
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
General disorders
Pyrexia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Bronchitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.62%
2/320 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Cellulitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Endophthalmitis
|
1.2%
4/322 • Number of events 4 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Pneumonia
|
1.6%
5/322 • Number of events 5 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.62%
2/320 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Tracheobronchitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.62%
2/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
2/322 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.93%
3/322 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
2/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.93%
3/322 • Number of events 3 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Cerebral haematoma
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Dizziness
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Polyneuropathy
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Seizure
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Psychiatric disorders
Anxiety
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Renal and urinary disorders
Calculus bladder
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.62%
2/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
2/322 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 2 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/322 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.31%
1/320 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
General disorders
Death
|
0.31%
1/322 • Number of events 1 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
0.00%
0/320 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
Other adverse events
| Measure |
E10030 + Bevacizumab or Aflibercept
n=322 participants at risk
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
|
Sham + Bevacizumab or Aflibercept
n=320 participants at risk
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
bevacizumab or aflibercept: Patients are randomized to receive either bevacizumab or aflibercept
E10030 sham injection: Pressure on the eye with a syringe with no needle
|
|---|---|---|
|
Investigations
Intraocular pressure increased
|
6.8%
22/322 • Number of events 46 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
6.2%
20/320 • Number of events 35 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
12.1%
39/322 • Number of events 85 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
9.7%
31/320 • Number of events 48 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Punctate keratitis
|
6.5%
21/322 • Number of events 34 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
4.4%
14/320 • Number of events 39 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Eye pain
|
5.6%
18/322 • Number of events 26 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
6.6%
21/320 • Number of events 35 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Vitreous detachment
|
6.2%
20/322 • Number of events 21 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
5.9%
19/320 • Number of events 23 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
5.0%
16/322 • Number of events 16 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
5.9%
19/320 • Number of events 19 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
14/322 • Number of events 15 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
5.3%
17/320 • Number of events 18 • All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.
AEs in the safety population (all subjects who received at least one dose of the study treatment) were collected for up to 12 months of exposure (Year 1). All AEs that ultimately resulted in death (regardless of the actual date of death) were included in All Cause Mortality count, and hence the count may differ from the Participant Flow Table which included reported deaths at the time of early discontinuation from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publications of the Study results with the other investigators and/or institutions only, upon prior written consent of Ophthotech.
- Publication restrictions are in place
Restriction type: OTHER