Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT03525600

Recruitment Status : Completed

First Posted : May 15, 2018

Results First Posted : June 18, 2023

Last Update Posted : June 18, 2023

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Sponsor:

Information provided by (Responsible Party):

Apellis Pharmaceuticals, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Geographic Atrophy
Interventions	Drug: APL-2 Other: Sham Procedure
Enrollment	621

Participant Flow

Recruitment Details	This Phase III, randomized, double-masked, sham injection-controlled study was conducted in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at 122 sites in 14 countries between 31 Aug 2018 and 20 Jun 2022.
Pre-assignment Details	This study consisted of a screening period (up to 30 days), a randomization visit on Day 1, and a treatment period (up to 24 months). Subjects were randomized in a 2:2:1:1 ratio on Day 1 to receive treatment with pegcetacoplan monthly, pegcetacoplan every other month (EOM), sham injection monthly or sham injection EOM, respectively. A total of 621 subjects were randomized in this study.


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Monthly	Sham EOM
Arm/Group Description	Subjects received intravitreal (IVT...	Subjects received IVT injections of...	Subjects received sham injections o...	Subjects received sham injections E...
Arm/Group Description	Subjects received intravitreal (IVT) injections of pegcetacoplan 15 milligram (mg)/0.1 milliliter (mL) once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Subjects received sham injections once monthly for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.	Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Period Title: Overall Study
Started	206	208	102	105
Completed	147	161	78	83
Not Completed	59	47	24	22
Reason Not Completed
Adverse Event	9	6	5	3
Lost to Follow-up	2	4	4	0
Physician Decision	1	0	2	0
Consent withdrawal	36	20	6	13
Death	7	6	4	3
Due to Coronavirus Disease-2019 (COVID-19) impact	4	10	3	3
Other	0	1	0	0

Baseline Characteristics

Arm/Group Title		Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled	Total
Arm/Group Description		Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...	Total of all reporting groups
Arm/Group Description		Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.	Total of all reporting groups
Overall Number of Baseline Participants		206	208	207	621
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The Intent-to-treat (ITT) analysis set consisted of all subjects assigned to treatment.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	206 participants	208 participants	207 participants	621 participants
		78.8 (6.91)	79.2 (7.06)	78.5 (7.24)	78.8 (7.07)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	206 participants	208 participants	207 participants	621 participants
	Female	121	126	132	379
	Male	85	82	75	242
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	206 participants	208 participants	207 participants	621 participants
White		192	192	200	584
Not reported		12	11	6	29
Black or African American		1	1	0	2
Asian		0	1	0	1
Multiple		0	1	0	1
Unknown		1	2	1	4
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	206 participants	208 participants	207 participants	621 participants
Hispanic or Latino		32	37	29	98
Not Hispanic or Latino		163	155	172	490
Not Reported		10	12	6	28
Unknown		1	4	0	5
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	206 participants	208 participants	207 participants	621 participants
United States		146	126	128	400
Argentina		18	24	18	60
France		12	14	7	33
Brazil		9	13	10	32
United Kingdom		5	6	10	21
Germany		3	4	11	18
Poland		2	7	6	15
Czechia		2	7	5	14
Australia		3	1	4	8
Canada		2	1	4	7
Israel		0	4	2	6
Italy		2	1	0	3
Spain		1	0	2	3
New Zealand		1	0	0	1
GA Lesion Size (fundus autofluorescence [FAF]) in the Study Eye Mean (Standard Deviation) Unit of measure: Millimeter square (mm^2)
	Number Analyzed	206 participants	208 participants	207 participants	621 participants
		8.3606 (4.16892)	8.2076 (3.91213)	8.2572 (4.21864)	8.2749 (4.09557)

Outcome Measures

1.Primary Outcome


Title	Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12
Description	The GA lesion area was measured by a quantified central reading center...
Description	The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time Frame	Baseline (screening) and Month 12

Outcome Measure Data

Analysis Population Description

The modified ITT (mITT) analysis set consisted of all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 12 were included in the analysis.


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled
Arm/Group Description:	Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...
Arm/Group Description:	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Overall Number of Participants Analyzed	200	199	193
Least Squares Mean (Standard Error) Unit of Measure: mm^2
	1.7344 (0.07924)	1.7563 (0.07446)	1.9640 (0.09592)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0615
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.2296
	Confidence Interval	(2-Sided) 95% -0.4703 to 0.0111
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0854
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.2077
	Confidence Interval	(2-Sided) 95% -0.4444 to 0.0290
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	LS Mean Change From Baseline in the Total Area of GA Lesions in the Study Eye at Month 24
Description	The GA lesion area was measured by a quantified central reading center...
Description	The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time Frame	Baseline (screening) and Month 24

Outcome Measure Data

Analysis Population Description

The mITT analysis set consisted of all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis.


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled
Arm/Group Description:	Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...
Arm/Group Description:	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Overall Number of Participants Analyzed	200	200	194
Least Squares Mean (Standard Error) Unit of Measure: mm^2
	3.2275 (0.12457)	3.3395 (0.13034)	3.9726 (0.16820)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) × analysis visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.7451
	Confidence Interval	(2-Sided) 95% -1.1539 to -0.3362
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) × analysis visit.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0030
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.6331
	Confidence Interval	(2-Sided) 95% -1.0508 to -0.2153
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24
Description	The mean change in GA lesion area through Month 24 was measured by ass...
Description	The mean change in GA lesion area through Month 24 was measured by assuming a piecewise linear trend in time with knots by FAF images at Months 6, 12, and 18 and was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time Frame	From Baseline (screening) through Month 24

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled
Arm/Group Description:	Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...
Arm/Group Description:	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Overall Number of Participants Analyzed	201	201	195
Least Squares Mean (Standard Error) Unit of Measure: mm^2
From Baseline to Month 6	0.9075 (0.04755)	0.8829 (0.04660)	0.9622 (0.04983)
From Month 6 to Month 12	0.8409 (0.05128)	0.8473 (0.05086)	1.0132 (0.05998)
From Month 12 to Month 18	0.9033 (0.04917)	0.8803 (0.05105)	1.0483 (0.05574)
From Month 18 to Month 24	0.6262 (0.06809)	0.6946 (0.05256)	0.9794 (0.05469)
From Baseline to Month 24	3.2780 (0.12525)	3.3051 (0.12871)	4.0031 (0.16880)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.4282
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.0547
	Confidence Interval	(2-Sided) 95% -0.1899 to 0.0806
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.2457
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.0793
	Confidence Interval	(2-Sided) 95% -0.2131 to 0.0546
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0292
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.1722
	Confidence Interval	(2-Sided) 95% -0.3270 to -0.0174
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0352
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.1659
	Confidence Interval	(2-Sided) 95% -0.3202 to -0.0115
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0514
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.1450
	Confidence Interval	(2-Sided) 95% -0.2909 to 0.0009
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0265
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.1680
	Confidence Interval	(2-Sided) 95% -0.3164 to -0.0196
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.3532
	Confidence Interval	(2-Sided) 95% -0.5245 to -0.1819
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.2848
	Confidence Interval	(2-Sided) 95% -0.4336 to -0.1361
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan Monthly, Sham Pooled
	Comments	Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.7251
	Confidence Interval	(2-Sided) 95% -1.1373 to -0.3129
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Pegcetacoplan EOM, Sham Pooled
	Comments	Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
	Type of Statistical Test	Superiority
	Comments	Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.

Statistical Test of Hypothesis	P-Value	0.0010
	Comments	[Not Specified]
	Method	MMRM model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference
	Estimated Value	-0.6980
	Confidence Interval	(2-Sided) 95% -1.1142 to -0.2817
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24
Description	The maximum reading speed of the study eye was calculated per Minnesot...
Description	The maximum reading speed of the study eye was calculated per Minnesota Low-Vision Reading Test (MNREAD) or Radner Reading Charts user manuals, with no adjustment for reading inaccuracy. An additional step to cap resulting reading speed values at a maximum of 300 words per minute (wpm) was implemented. Maximum reading speed was calculated as the mean of the 3 highest non-zero reading speeds (or 2, or 1 value, as available), except when all wpm were calculated as 0 then the maximum reading speed was calculated as 0. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time Frame	Baseline (screening) and Month 24

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled
Arm/Group Description:	Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...
Arm/Group Description:	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Overall Number of Participants Analyzed	179	163	164
Least Squares Mean (Standard Error) Unit of Measure: wpm
	-22.897 (4.1171)	-25.532 (2.7676)	-22.355 (2.9341)

5.Secondary Outcome


Title	LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24
Description	The FRI was an interviewer-administered questionnaire with 7 items on ...
Description	The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD subjects. It had 1 total index score. For each FRI Index reading activity performed in the past 7 days, subjects were asked about the extent to which they required assistance beyond eyeglasses/contact lenses, including the use of low-vision aids, adjustments in the activity, or help from another subject. Mean FRI Index scores ranged from 1 (unable to do independently) to 4 (totally independent), with higher scores indicating higher functional reading independence. A negative change from baseline indicated a decrease in the FRI; disease worsening. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time Frame	Baseline (screening) and Month 24

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled
Arm/Group Description:	Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...
Arm/Group Description:	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Overall Number of Participants Analyzed	186	183	178
Least Squares Mean (Standard Error) Unit of Measure: scores on a scale
	-0.408 (0.0570)	-0.371 (0.0562)	-0.360 (0.0601)

6.Secondary Outcome


Title	LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24
Description	The NL-BCVA was assessed by early treatment diabetic retinopathy study...
Description	The NL-BCVA was assessed by early treatment diabetic retinopathy study (ETDRS) chart prior to dilating the eyes at a starting distance of 4 meters and ranged from 0 (least score) to 100 (best score). If the 4-meter score was >19 letters read correctly, the visual acuity score was the sum of total letters correctly read at 4 meters plus the addition of 30. If the 4-meter score was ≤19 letters read correctly, the visual acuity score was the sum of total letters read correctly at 4 meters and total letters read correctly at the 1-meter distance. If no letters were read correctly at either the 4-meter distance or the 1-meter distance, the visual acuity score was 0. A positive change in the value indicated improvement in visual acuity. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time Frame	Baseline (screening) and Month 24

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Pegcetacoplan Monthly	Pegcetacoplan EOM	Sham Pooled
Arm/Group Description:	Subjects received IVT injections of...	Subjects received IVT injections of...	Sham Monthly: Subjects received sha...
Arm/Group Description:	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.	Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.	Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Overall Number of Participants Analyzed	201	201	195
Least Squares Mean (Standard Error) Unit of Measure: ETDRS letter score
	-8.126 (1.0182)	-8.947 (1.0322)	-6.217 (1.0167)

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) were reported from first study drug administration (Day 1) up to the last visit or early termination visit, 30 days after the last study drug administration for the monthly treatment groups and 60 days after the last study drug administration for the EOM treatment groups, a maximum of 24 months
Adverse Event Reporting Description	The Safety analysis set consisted of all randomized subjects who received at least 1 injection of pegcetacoplan or sham. Ocular TEAEs are presented separately for the study and fellow eyes, and non-ocular (systemic) TEAEs are also presented.

Arm/Group Title	Pegcetacoplan Monthly: Ocular Study Eye		Pegcetacoplan EOM: Ocular Study Eye		Sham Pooled: Ocular Study Eye		Pegcetacoplan Monthly: Ocular Fellow Eye		Pegcetacoplan EOM: Ocular Fellow Eye		Sham Pooled: Ocular Fellow Eye		Pegcetacoplan Monthly: Non-ocular		Pegcetacoplan EOM: Non-ocular		Sham Pooled: Non-ocular
Arm/Group Description	Ocular TEAEs were summarized for th...		Ocular TEAEs were summarized for th...		Ocular TEAEs were summarized for th...		Ocular TEAEs were summarized for th...		Ocular TEAEs were summarized for th...		Ocular TEAEs were summarized for th...		Non-ocular (systemic) TEAEs were su...		Non-ocular (systemic) TEAEs were su...		Non-ocular (systemic) TEAEs were su...
Arm/Group Description	Ocular TEAEs were summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.		Ocular TEAEs were summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.		Ocular TEAEs were summarized for the study eye for all subjects who were randomized to sham monthly and sham EOM treatment groups. Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.		Ocular TEAEs were summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.		Ocular TEAEs were summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.		Ocular TEAEs were summarized for the fellow eye for all subjects who were randomized to sham monthly and sham EOM treatment groups. Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.		Non-ocular (systemic) TEAEs were summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.		Non-ocular (systemic) TEAEs were summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.		Non-ocular (systemic) TEAEs were summarized for all subjects who were randomized to sham monthly and sham EOM treatment groups. Sham Monthly: Subjects received sham injections once monthly for 24 months. Sham EOM: Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
All-Cause Mortality
	Pegcetacoplan Monthly: Ocular Study Eye		Pegcetacoplan EOM: Ocular Study Eye		Sham Pooled: Ocular Study Eye		Pegcetacoplan Monthly: Ocular Fellow Eye		Pegcetacoplan EOM: Ocular Fellow Eye		Sham Pooled: Ocular Fellow Eye		Pegcetacoplan Monthly: Non-ocular		Pegcetacoplan EOM: Non-ocular		Sham Pooled: Non-ocular
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/206 (0.00%)		0/208 (0.00%)		0/206 (0.00%)		0/206 (0.00%)		0/208 (0.00%)		0/206 (0.00%)		8/206 (3.88%)		6/208 (2.88%)		8/206 (3.88%)
Serious Adverse Events Serious Adverse Events
	Pegcetacoplan Monthly: Ocular Study Eye		Pegcetacoplan EOM: Ocular Study Eye		Sham Pooled: Ocular Study Eye		Pegcetacoplan Monthly: Ocular Fellow Eye		Pegcetacoplan EOM: Ocular Fellow Eye		Sham Pooled: Ocular Fellow Eye		Pegcetacoplan Monthly: Non-ocular		Pegcetacoplan EOM: Non-ocular		Sham Pooled: Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/206 (1.94%)		2/208 (0.96%)		2/206 (0.97%)		1/206 (0.49%)		1/208 (0.48%)		0/206 (0.00%)		61/206 (29.61%)		47/208 (22.60%)		53/206 (25.73%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	1/206 (0.49%)	1
Febrile neutropenia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Cardiac disorders
Atrial fibrillation ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	3/206 (1.46%)	3	2/208 (0.96%)	3	0/206 (0.00%)	0
Cardiac failure congestive ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	3/206 (1.46%)	3	1/208 (0.48%)	1	1/206 (0.49%)	1
Cardiac failure ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	2/208 (0.96%)	2	1/206 (0.49%)	2
Angina pectoris ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Bradycardia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Myocardial infarction ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	0/208 (0.00%)	0	1/206 (0.49%)	1
Acute coronary syndrome ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Aortic valve stenosis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Arrhythmia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Atrioventricular block complete ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	1/206 (0.49%)	1
Cardiac arrest ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Cardiogenic shock ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Coronary artery disease ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	1/206 (0.49%)	1
Coronary artery stenosis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Ischaemic cardiomyopathy ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Left ventricular failure ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Mitral valve incompetence ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Cardiac failure chronic ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Ear and labyrinth disorders
Vertigo ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Endocrine disorders
Inappropriate antidiuretic hormone secretion ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Eye disorders
Uveitis ^† 1	0/206 (0.00%)	0	2/208 (0.96%)	2	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Vitritis ^† 1	2/206 (0.97%)	2	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Iridocyclitis ^† 1	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Optic ischaemic neuropathy ^† 1	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Retinal tear ^† 1	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Visual acuity reduced ^† 1	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Dry age-related macular degeneration ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Macular hole ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Cataract ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Gastrointestinal disorders
Gastrointestinal haemorrhage ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	0/208 (0.00%)	0	1/206 (0.49%)	1
Colitis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Diarrhoea ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Hiatus hernia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Intestinal obstruction ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Nausea ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Pancreatitis acute ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Rectal haemorrhage ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Colitis microscopic ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Rectal prolapse ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
General disorders
Asthenia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Fatigue ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Death ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Ill-defined disorder ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Influenza like illness ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Pyrexia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	2/206 (0.97%)	2
Hepatobiliary disorders
Cholelithiasis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	0/208 (0.00%)	0	0/206 (0.00%)	0
Infections and infestations
Pneumonia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	7/208 (3.37%)	7	3/206 (1.46%)	3
COVID-19 ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	3/208 (1.44%)	3	1/206 (0.49%)	1
Sepsis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	4/208 (1.92%)	4	0/206 (0.00%)	0
Urinary tract infection ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	2/208 (0.96%)	2	3/206 (1.46%)	4
Diverticulitis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	0/208 (0.00%)	0	0/206 (0.00%)	0
Influenza ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	2/208 (0.96%)	2	0/206 (0.00%)	0
Urosepsis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	1/206 (0.49%)	1
Bronchitis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
COVID-19 pneumonia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	1/206 (0.49%)	1
Cellulitis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	2	0/206 (0.00%)	0
Gastroenteritis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Infected skin ulcer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	3	0/208 (0.00%)	0	0/206 (0.00%)	0
Infective exacerbation of chronic obstructive airways disease ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Kidney infection ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Pathogen resistance ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Lower respiratory tract infection ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Injury, poisoning and procedural complications
Fall ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	3/206 (1.46%)	3	3/208 (1.44%)	3	1/206 (0.49%)	1
Femur fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	1/208 (0.48%)	1	2/206 (0.97%)	2
Ankle fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Humerus fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Anaesthetic complication ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Back injury ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Cervical vertebral fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Femoral neck fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	1/206 (0.49%)	1
Foot fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Head injury ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Hip fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	2/206 (0.97%)	2
Joint injury ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Lower limb fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Procedural pneumothorax ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Radius fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Rib fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	2/206 (0.97%)	2
Spinal compression fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Subdural haemorrhage ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	2	0/208 (0.00%)	0	0/206 (0.00%)	0
Ulna fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Post procedural haemorrhage ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Road traffic accident ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Skin laceration ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Spinal fracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Investigations
Breath sounds abnormal ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Metabolism and nutrition disorders
Electrolyte imbalance ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Fluid overload ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Fluid retention ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Hyperglycaemia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Hypokalaemia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Hyponatraemia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Arthralgia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Dupuytren's contracture ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Joint swelling ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Osteoarthritis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	2/206 (0.97%)	2
Lumbar spinal stenosis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Spondylolisthesis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Breast cancer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	1/206 (0.49%)	1
B-cell lymphoma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Bladder cancer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	1/206 (0.49%)	1
Endometrial cancer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Hairy cell leukaemia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Laryngeal cancer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Laryngeal cancer recurrent ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Lip neoplasm ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Lung adenocarcinoma stage II ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Lung adenocarcinoma stage III ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Plasma cell myeloma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Prostate cancer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Squamous cell carcinoma of lung ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	1/206 (0.49%)	1
Squamous cell carcinoma of the oral cavity ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	1/206 (0.49%)	1
Superficial spreading melanoma stage III ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Acoustic neuroma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Adenocarcinoma of colon ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	2/206 (0.97%)	2
Basal cell carcinoma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Bladder transitional cell carcinoma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Colon cancer ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Lung carcinoma cell type unspecified stage I ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Lung neoplasm malignant ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Malignant melanoma ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Neoplasm malignant ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Nervous system disorders
Cerebrovascular accident ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	5/206 (2.43%)	5	2/208 (0.96%)	2	3/206 (1.46%)	3
Syncope ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	4/206 (1.94%)	4	2/208 (0.96%)	2	1/206 (0.49%)	1
Transient ischaemic attack ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	2/208 (0.96%)	3	0/206 (0.00%)	0
Cerebellar infarction ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Cerebral infarction ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Dizziness ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Embolic stroke ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Epilepsy ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Haemorrhagic stroke ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Headache ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	2	0/206 (0.00%)	0
Intracranial aneurysm ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Loss of consciousness ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	3	0/208 (0.00%)	0	1/206 (0.49%)	1
Presyncope ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Sciatica ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Seizure ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Subarachnoid haemorrhage ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Carotid artery stenosis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Metabolic encephalopathy ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Psychiatric disorders
Major depression ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Panic attack ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Disorientation ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Renal and urinary disorders
Acute kidney injury ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	2/208 (0.96%)	2	1/206 (0.49%)	1
Haematuria ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Urinary retention ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Ureterolithiasis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Reproductive system and breast disorders
Pelvic prolapse ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	1/208 (0.48%)	1	0/206 (0.00%)	0
Pneumonia aspiration ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	2/208 (0.96%)	2	0/206 (0.00%)	0
Acute respiratory failure ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	1/208 (0.48%)	1	0/206 (0.00%)	0
Chronic respiratory failure ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Hypoxia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Pneumothorax ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Pulmonary embolism ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	1/206 (0.49%)	1
Pulmonary hypertension ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Respiratory distress ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Respiratory failure ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Skin and subcutaneous tissue disorders
Drug eruption ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Precancerous skin lesion ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Rash ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Skin exfoliation ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Vascular disorders
Hypotension ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	2/206 (0.97%)	2	1/208 (0.48%)	1	0/206 (0.00%)	0
Accelerated hypertension ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Deep vein thrombosis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Hypertensive crisis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	1/208 (0.48%)	1	0/206 (0.00%)	0
Hypertensive emergency ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	1/206 (0.49%)	1	0/208 (0.00%)	0	0/206 (0.00%)	0
Aortic stenosis ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
Hypertension ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	1/206 (0.49%)	1
1 Term from vocabulary, MedDRA 23.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pegcetacoplan Monthly: Ocular Study Eye		Pegcetacoplan EOM: Ocular Study Eye		Sham Pooled: Ocular Study Eye		Pegcetacoplan Monthly: Ocular Fellow Eye		Pegcetacoplan EOM: Ocular Fellow Eye		Sham Pooled: Ocular Fellow Eye		Pegcetacoplan Monthly: Non-ocular		Pegcetacoplan EOM: Non-ocular		Sham Pooled: Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	113/206 (54.85%)		82/208 (39.42%)		61/206 (29.61%)		35/206 (16.99%)		34/208 (16.35%)		29/206 (14.08%)		90/206 (43.69%)		70/208 (33.65%)		101/206 (49.03%)
Eye disorders
Vitreous floaters ^† 1	24/206 (11.65%)	29	10/208 (4.81%)	12	3/206 (1.46%)	3	3/206 (1.46%)	3	1/208 (0.48%)	1	4/206 (1.94%)	4	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Neovascular age-related macular degeneration ^† 1	21/206 (10.19%)	22	10/208 (4.81%)	10	5/206 (2.43%)	6	7/206 (3.40%)	8	11/208 (5.29%)	11	8/206 (3.88%)	8	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Conjunctival haemorrhage ^† 1	12/206 (5.83%)	16	15/208 (7.21%)	21	5/206 (2.43%)	6	1/206 (0.49%)	1	4/208 (1.92%)	4	1/206 (0.49%)	1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Retinal haemorrhage ^† 1	9/206 (4.37%)	9	15/208 (7.21%)	15	8/206 (3.88%)	9	2/206 (0.97%)	3	4/208 (1.92%)	5	7/206 (3.40%)	8	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Visual acuity reduced ^† 1	16/206 (7.77%)	16	6/208 (2.88%)	8	10/206 (4.85%)	11	10/206 (4.85%)	11	6/208 (2.88%)	7	4/206 (1.94%)	4	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Vitreous detachment ^† 1	8/206 (3.88%)	8	14/208 (6.73%)	14	6/206 (2.91%)	6	8/206 (3.88%)	8	4/208 (1.92%)	4	3/206 (1.46%)	3	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Eye pain ^† 1	13/206 (6.31%)	18	8/208 (3.85%)	9	13/206 (6.31%)	15	2/206 (0.97%)	2	2/208 (0.96%)	3	1/206 (0.49%)	1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Eye irritation ^† 1	10/206 (4.85%)	13	4/208 (1.92%)	5	11/206 (5.34%)	12	2/206 (0.97%)	2	2/208 (0.96%)	2	1/206 (0.49%)	1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0
Gastrointestinal disorders
Diarrhoea ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	6/206 (2.91%)	6	8/208 (3.85%)	8	12/206 (5.83%)	12
Nausea ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	11/206 (5.34%)	12	1/208 (0.48%)	1	5/206 (2.43%)	5
Infections and infestations
Urinary tract infection ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	17/206 (8.25%)	30	13/208 (6.25%)	15	21/206 (10.19%)	36
COVID-19 ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	8/206 (3.88%)	8	7/208 (3.37%)	7	11/206 (5.34%)	11
Injury, poisoning and procedural complications
Fall ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	10/206 (4.85%)	16	15/208 (7.21%)	20	21/206 (10.19%)	30
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	12/206 (5.83%)	13	4/208 (1.92%)	5	6/206 (2.91%)	7
Arthralgia ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	10/206 (4.85%)	16	6/208 (2.88%)	8	14/206 (6.80%)	16
Vascular disorders
Hypertension ^† 1	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	0/206 (0.00%)	0	0/208 (0.00%)	0	0/206 (0.00%)	0	17/206 (8.25%)	18	16/208 (7.69%)	16	15/206 (7.28%)	15
1 Term from vocabulary, MedDRA 23.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Apellis Clinical Trial Information Line
Organization:	Apellis Pharmaceuticals, Inc
Phone:	1-833-284-6361
EMail:	clinicaltrials@apellis.com

Layout table for additonal information

Responsible Party:	Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT03525600
Other Study ID Numbers:	APL2-303
First Submitted:	April 20, 2018
First Posted:	May 15, 2018
Results First Submitted:	May 24, 2023
Results First Posted:	June 18, 2023
Last Update Posted:	June 18, 2023

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