Trial Outcomes & Findings for Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT) (NCT NCT02745119)
NCT ID: NCT02745119
Last Updated: 2019-03-06
Results Overview
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
TERMINATED
PHASE3
994 participants
Up to approximately one year
2019-03-06
Participant Flow
994 participants enrolled in study . study terminated early by Sponsor due to lack of efficacy. 842 patients received at least one lampalizumab injection 152 patients enrolled in Study GX30191 did not receive study drug in the extension study and thus were excluded from the safety-evaluable population.
Eligible participants were those who enrolled in Studies GX29176 (NCT02247479) and GX29185 (NCT02247531) and had completed the 96-week treatment period without early treatment discontinuation or study discontinuation.
Participant milestones
| Measure |
Lampalizumab Q4W - Treatment-Naive
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
145
|
274
|
146
|
277
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
145
|
274
|
146
|
277
|
Reasons for withdrawal
| Measure |
Lampalizumab Q4W - Treatment-Naive
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
3
|
|
Overall Study
Death
|
3
|
3
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
15
|
8
|
14
|
|
Overall Study
Study Terminated by Sponsor
|
134
|
252
|
135
|
251
|
|
Overall Study
Physician Decision
|
0
|
2
|
2
|
2
|
|
Overall Study
Reason Not Specified
|
0
|
2
|
0
|
1
|
Baseline Characteristics
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Baseline characteristics by cohort
| Measure |
Lampalizumab Q4W - Treatment-Naive
n=145 Participants
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
n=274 Participants
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
n=146 Participants
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
n=277 Participants
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Total
n=842 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
79.0 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
78.7 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
79.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
80.2 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
79.3 years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
492 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
350 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
145 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
827 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
263 Participants
n=4 Participants
|
810 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to approximately one yearPopulation: The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Outcome measures
| Measure |
Lampalizumab Q4W - Treatment-Naive
n=145 Participants
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
n=274 Participants
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
n=146 Participants
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
n=277 Participants
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
All Participants
n=842 Participants
All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Mild
|
25.5 percentage of participants
|
26.6 percentage of participants
|
16.4 percentage of participants
|
21.7 percentage of participants
|
23.0 percentage of participants
|
|
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Moderate
|
9.7 percentage of participants
|
11.3 percentage of participants
|
8.2 percentage of participants
|
10.1 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Any severity
|
37.2 percentage of participants
|
40.1 percentage of participants
|
24.7 percentage of participants
|
33.2 percentage of participants
|
34.7 percentage of participants
|
|
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Severe
|
2.1 percentage of participants
|
2.2 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
1.5 percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately one yearPopulation: The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
Outcome measures
| Measure |
Lampalizumab Q4W - Treatment-Naive
n=145 Participants
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
n=274 Participants
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
n=146 Participants
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
n=277 Participants
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
All Participants
n=842 Participants
All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Mild
|
18.6 percentage of participants
|
20.1 percentage of participants
|
17.8 percentage of participants
|
20.9 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Severe
|
8.3 percentage of participants
|
13.5 percentage of participants
|
5.5 percentage of participants
|
10.1 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Any severity
|
55.2 percentage of participants
|
54.0 percentage of participants
|
41.8 percentage of participants
|
51.3 percentage of participants
|
51.2 percentage of participants
|
|
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Moderate
|
28.3 percentage of participants
|
20.4 percentage of participants
|
18.5 percentage of participants
|
20.2 percentage of participants
|
21.4 percentage of participants
|
PRIMARY outcome
Timeframe: Week 48Population: The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study. Data is reported for evaluable participants.
The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.
Outcome measures
| Measure |
Lampalizumab Q4W - Treatment-Naive
n=145 Participants
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
n=274 Participants
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
n=146 Participants
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
n=277 Participants
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
All Participants
n=842 Participants
All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Anti-Lampalizumab Antibodies
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Lampalizumab Q4W - Treatment-Naive
Lampalizumab Q4W - Previously Treated
Lampalizumab Q6W - Treatment-Naive
Lampalizumab Q6W - Previously Treated
All Participants
Serious adverse events
| Measure |
Lampalizumab Q4W - Treatment-Naive
n=145 participants at risk
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
n=274 participants at risk
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
n=146 participants at risk
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
n=277 participants at risk
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
All Participants
n=842 participants at risk
All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.4%
4/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.48%
4/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Visual acuity reduced
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.5%
4/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.95%
8/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.59%
5/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Visual impairment
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Dellen
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Dry age-related macular degeneration
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Iritis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Vitreous haemorrhage
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Investigations
Intraocular pressure increased
|
2.1%
3/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.5%
4/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.8%
5/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.5%
13/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.1%
3/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.71%
6/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Bradycardia
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Myocardial infarction
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Angina pectoris
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Colitis
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Malabsorption
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
General disorders
Chest pain
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.59%
5/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
General disorders
Death
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.1%
3/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.48%
4/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Pneumonia
|
2.1%
3/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.4%
2/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.8%
5/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.4%
12/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Influenza
|
1.4%
2/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.59%
5/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Sepsis
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Central nervous system infection
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Urinary tract infection
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.5%
4/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.8%
5/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.2%
10/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
1.1%
3/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Investigations
International normalised ratio increased
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.73%
2/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Dementia with lewy bodies
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.72%
2/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
3/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.24%
2/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Aortic calcification
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.68%
1/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Cataract
|
0.69%
1/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.00%
0/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.36%
1/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
0.12%
1/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
Other adverse events
| Measure |
Lampalizumab Q4W - Treatment-Naive
n=145 participants at risk
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
|
Lampalizumab Q4W - Previously Treated
n=274 participants at risk
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
|
Lampalizumab Q6W - Treatment-Naive
n=146 participants at risk
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
Lampalizumab Q6W - Previously Treated
n=277 participants at risk
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
|
All Participants
n=842 participants at risk
All participants in the study received lampalizumab 10 mg, ITV, Q4W or Q6W.
|
|---|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
11.7%
17/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
6.2%
17/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
8.2%
12/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
7.2%
20/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
7.8%
66/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Eye disorders
Eye pain
|
5.5%
8/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
2.9%
8/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
3.4%
5/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
4.0%
11/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
3.8%
32/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
11/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
4.4%
12/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
2.1%
3/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
2.2%
6/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
3.8%
32/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
11/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
4.4%
12/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
3.4%
5/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
5.1%
14/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
5.0%
42/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
|
Investigations
Intraocular pressure increased
|
1.4%
2/145 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
8.4%
23/274 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
3.4%
5/146 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
6.1%
17/277 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
5.6%
47/842 • Up to approximately one year
The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER