Trial Outcomes & Findings for A Study of NGM621 in Participants With Geographic Atrophy (NCT NCT04465955)

NCT ID: NCT04465955

Last Updated: 2025-07-01

Results Overview

The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 320 participants
• Primary outcome timeframe: Baseline to Week 52
• Results posted on: 2025-07-01

Participant Flow

A total of 320 participants who met all inclusion criteria and no exclusion criteria were randomized to 1 of 4 treatment groups (NGM621 treatment or sham comparator administered either every 4 weeks or every 8 weeks) at 65 sites in the United States. Participants were randomized to 1 of the 4 treatment groups in a ratio of 2 (NGM621 Q4W):1 (Placebo Q4W):2 (NGM621 Q8W):1 (Placebo Q8W).

Participant milestones

Measure	NGM621 Q4W Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Overall Study STARTED	108	105	107
Overall Study Received Treatment	108	104	106
Overall Study COMPLETED	93	89	93
Overall Study NOT COMPLETED	15	16	14

Reasons for withdrawal

Measure	NGM621 Q4W Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Overall Study Withdrew consent	6	10	7
Overall Study Adverse Event	6	5	1
Overall Study Lost to Follow-up	2	0	3
Overall Study Other	1	1	3

Baseline Characteristics

A Study of NGM621 in Participants With Geographic Atrophy

Baseline characteristics by cohort

Measure	NGM621 Q4W n=108 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=104 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=106 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	Total n=318 Participants Total of all reporting groups
Age, Continuous	78.5 years STANDARD_DEVIATION 8.17 • n=5 Participants	79.1 years STANDARD_DEVIATION 7.51 • n=7 Participants	77.6 years STANDARD_DEVIATION 8.42 • n=5 Participants	78.4 years STANDARD_DEVIATION 8.04 • n=4 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	63 Participants n=7 Participants	68 Participants n=5 Participants	198 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	41 Participants n=7 Participants	38 Participants n=5 Participants	120 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	107 Participants n=5 Participants	102 Participants n=7 Participants	101 Participants n=5 Participants	310 Participants n=4 Participants
Region of Enrollment United States	108 participants n=5 Participants	104 participants n=7 Participants	106 participants n=5 Participants	318 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: The rate of change from baseline in the GA lesion area was assessed in the modified Intent-to-Treat population.

The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.

Outcome measures

Measure	NGM621 Q4W n=108 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=104 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=106 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area	2.243 mm^2 per year Standard Error 0.138	2.237 mm^2 per year Standard Error 0.140	2.393 mm^2 per year Standard Error 0.138

PRIMARY outcome

Timeframe: Baseline to end of study (Week 56)

Population: TEAEs were assessed in the Safety Analysis Set.

A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment.

Outcome measures

Measure	NGM621 Q4W n=108 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=104 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=106 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye Any Serious TEAE	8 Participants	8 Participants	3 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye Any TEAE	57 Participants	51 Participants	49 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye Any Treatment-related TEAE	6 Participants	5 Participants	1 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye Any TEAE Leading to Treatment Discontinuation	0 Participants	1 Participants	0 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye Any Sight Threatening TEAE	6 Participants	6 Participants	3 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye Any Severe TEAE	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in GA lesion area was assessed in participants with available data in the modified Intent-to-Treat population.

Geographic atrophy lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.

Outcome measures

Measure	NGM621 Q4W n=90 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=89 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=90 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Geographic Atrophy (GA) Lesion Area	2.172 mm^2 Standard Deviation 1.5026	2.235 mm^2 Standard Deviation 1.4203	2.479 mm^2 Standard Deviation 1.4028

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The rate of change from baseline in the square root of GA lesion area was assessed in participants with available data in the modified Intent-to-Treat population.

Geographic atrophy lesion area was measured by fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions.

Outcome measures

Measure	NGM621 Q4W n=90 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=89 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=90 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area	0.389 mm^2 per year Standard Deviation 0.2352	0.388 mm^2 per year Standard Deviation 0.2200	0.423 mm^2 per year Standard Deviation 0.2225

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Best Corrected Visual Acuity Score was assessed in participants with available data in the modified Intent-to-Treat population.

Best Corrected Visual Acuity Score is the best possible vision an eye can achieve with corrective lenses, typically glasses or contact lenses. BCVA was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision.

The change from baseline in BCVA is being report with negative scores indicating an improvement in vision.

Outcome measures

Measure	NGM621 Q4W n=88 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=85 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=88 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Best Corrected Visual Acuity Score	-2.7 score on a scale Standard Deviation 9.55	-5.6 score on a scale Standard Deviation 12.80	-2.7 score on a scale Standard Deviation 9.71

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Low Luminance Visual Acuity Score was assessed in participants with available data in the modified Intent-to-Treat population.

Low Luminance Visual Acuity Score measures vision in low-light conditions. It was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.

ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision.

A lower (negative) LLVA score compared to baseline indicates a decline in visual acuity. A higher (positive) LLVA score compared to baseline indicates an improvement in visual acuity.

Outcome measures

Measure	NGM621 Q4W n=92 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=88 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=88 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Low Luminance Visual Acuity Score	0.1 score on a scale Standard Deviation 12.38	-1.4 score on a scale Standard Deviation 12.45	-2.31 score on a scale Standard Deviation 13.00

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Low Luminance Deficit Score was assessed in participants with available data in the modified Intent-to-Treat population.

Low Luminance Deficit (LLD) Score was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) letters at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision.

A LLD is the difference between standard visual acuity and LLVA, with a LLD >13 ETDRS letters suggesting potential visual abnormality. The change from baseline in LLD is being report with negative scores indicating an improvement in vision.

Outcome measures

Measure	NGM621 Q4W n=92 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=88 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=88 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Low Luminance Deficit Score	-2.9 score on a scale Standard Deviation 13.48	-5.3 score on a scale Standard Deviation 16.16	-0.5 score on a scale Standard Deviation 14.10

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Binocular Reading Speed was assessed in participants with available data in the modified Intent-to-Treat population.

Average binocular reading speed was assessed by Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. The change from baseline in average binocular reading speed is reported with a higher (positive) reading speed (wpm) indicates better reading ability, while a lower (negative) reading speed indicates poorer reading ability.

Outcome measures

Measure	NGM621 Q4W n=66 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=58 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=68 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Average Binocular Reading Speed	-9.17 words per minute Standard Deviation 39.154	-16.90 words per minute Standard Deviation 36.853	-8.70 words per minute Standard Deviation 39.844

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Binocular Critical Print Size was assessed in participants with available data in the modified Intent-to-Treat population.

Binocular critical print size was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). The change from baseline in binocular critical print size is being reported with a higher (positive) LogMAR value for critical print size indicating that a person needs larger print sizes to maintain their maximum reading speed, while a lower (negative) LogMAR value indicates that they can read smaller print sizes at their maximum speed.

Outcome measures

Measure	NGM621 Q4W n=66 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=58 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=68 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Binocular Critical Print Size	-0.01 logMAR Standard Deviation 0.290	-0.01 logMAR Standard Deviation 0.334	0 logMAR Standard Deviation 0.280

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Binocular Reading Acuity was assessed in participants with available data in the modified Intent-to-Treat population.

Binocular reading acuity was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). Binocular reading acuity is the smallest print size (in LogMAR) that a person can read easily and accurately. The change from baseline in binocular reading acuity is being reported with a higher LogMAR value for reading acuity indicates poorer reading ability, while a lower LogMAR value indicates better reading ability.

Outcome measures

Measure	NGM621 Q4W n=79 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=79 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=80 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Binocular Reading Acuity	0.047 logMAR Standard Deviation 0.2760	0.086 logMAR Standard Deviation 0.2812	0.058 logMAR Standard Deviation 0.2455

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Functional Reading Independence Index was assessed in participants with available data in the modified Intent-to-Treat population.

The Functional Reading Independence (FRI) Index Composite Score is a 7-item patient questionnaire developed to evaluate the effect of geography atrophy on a patient's ability to independently perform reading activities. The FRI Index yields mean scores ranging from 1-4, with 1=unable to do and 4=totally independent. The FRI Index composite score is calculated by averaging the item-level scores across the seven questions, higher sores indicate better FRI. The change from baseline in FRI is being reported with lower (negative) values indicating a decline in FRI.

Outcome measures

Measure	NGM621 Q4W n=91 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=88 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=90 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Functional Reading Independence Index Composite Score	-0.14 score on a scale Standard Deviation 0.597	-0.15 score on a scale Standard Deviation 0.512	-0.20 score on a scale Standard Deviation 0.675

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in National Eye Institute Visual Functioning Questionnaire was assessed in participants with available data in the modified Intent-to-Treat population.

The National Eye Institute Visual Functioning Questionnaire Composite Score is calculated by averaging the scores of the 11 vision-targeted subscales, excluding the general health rating question, on a scale of 0 to 100, with higher scores indicating better vision-related function. The change from baseline is being reported with a negative value indicating a decline in vision function.

Outcome measures

Measure	NGM621 Q4W n=91 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=88 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=91 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score	-1.97 score on a scale Standard Deviation 11.075	-3.74 score on a scale Standard Deviation 10.024	-2.96 score on a scale Standard Deviation 11.549

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The change from baseline in Systemic Complement Activity was assessed in participants with available data in the modified Intent-to-Treat population.

Systemic Complement Activity is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. CH50 levels of 41 to 90 hemolytic units per mL (U/mL) is considered normal. The change from baseline in CH50 is being reported.

Outcome measures

Measure	NGM621 Q4W n=77 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=70 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=75 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
The Change From Baseline in Systemic Complement Activity (CH50)	18.16 units/mL Standard Deviation 51.339	24.17 units/mL Standard Deviation 56.244	26.595 units/mL Standard Deviation 54.077

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: ADA-negative participants were assessed in participants with available data in the Safety Analysis Set.

The incidence of anti-drug antibody (ADA) was assessed in serum.

Outcome measures

Measure	NGM621 Q4W n=93 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=86 Participants Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=85 Participants Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Number of Anti-Drug Antibody (ADA)-Negative Participants	93 Participants	86 Participants	85 Participants

Adverse Events

NGM621 Q4W

Serious events: 32 serious events

Other events: 33 other events

Deaths: 4 deaths

NGM621 Q8W

Serious events: 24 serious events

Other events: 34 other events

Deaths: 2 deaths

Sham Q4W+Q8W

Serious events: 29 serious events

Other events: 31 other events

Deaths: 2 deaths

Serious adverse events

Measure	NGM621 Q4W n=108 participants at risk Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=104 participants at risk Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=106 participants at risk Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Transient ischaemic attack	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Dry age-related macular degeneration	3.7% 4/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	3.8% 4/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	2.8% 3/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Visual acuity reduced	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	2.9% 3/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Visual impairment	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	1.9% 2/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Retinal artery occlusion	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Neovascular age-related macular degeneration	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Rhegmatogenous retinal detachment	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Vitreous haemorrhage	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Atrial fibrillation	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	1.9% 2/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	1.9% 2/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Cardiac failure acute	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	1.9% 2/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Cardiac failure congestive	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Angina unstable	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Atrial flutter	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Coronary artery disease	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Ventricular tachycardia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Arrhythmia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Atrioventricular block complete	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Cardiac disorders Myocardial infarction	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Gastrointestinal disorders Faecaloma	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Gastrointestinal disorders Colitis	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Gastrointestinal disorders Enterocolitis	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
General disorders Asthenia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
General disorders Death	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations COVID-19 pneumonia	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations COVID-19	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	1.9% 2/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations Pneumonia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	1.9% 2/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	2.8% 3/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations Escherichia urinary tract infection	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations Pneumonia aspiration	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations Pneumonia viral	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations Urinary tract infection	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Fall	2.8% 3/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Confusion postoperative	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Femur fracture	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Head injury	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Hip fracture	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Skull fracture	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Tibia fracture	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Back pain	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Groin pain	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Bursitis	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage II	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Encephalopathy	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Intracranial haematoma	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Sciatica	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Toxic encephalopathy	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Cerebrovascular accident	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Myelopathy	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Nervous system disorders Nervous system disorder	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Psychiatric disorders Completed suicide	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Psychiatric disorders Mental status changes	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Renal and urinary disorders Bladder outlet obstruction	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Renal and urinary disorders Acute kidney injury	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.94% 1/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Vascular disorders Aortic stenosis	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Vascular disorders Hypertension	0.93% 1/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Vascular disorders Hypertensive crisis	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Vascular disorders Hypertensive emergency	0.00% 0/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.96% 1/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.

Other adverse events

Measure	NGM621 Q4W n=108 participants at risk Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W).	NGM621 Q8W n=104 participants at risk Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W).	Sham Q4W+Q8W n=106 participants at risk Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Conjunctival haemorrhage	13.0% 14/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	13.5% 14/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	7.5% 8/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Visual acuity reduced	4.6% 5/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	7.7% 8/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	5.7% 6/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Dry age-related macular degeneration	6.5% 7/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	4.8% 5/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	6.6% 7/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Visual impairment	4.6% 5/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	6.7% 7/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	3.8% 4/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
Eye disorders Retinal haemorrhage (fellow eye)	1.9% 2/108 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	0.00% 0/104 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.	5.7% 6/106 • Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.

Additional Information

VP, Clinical Operations

NGM Biopharmaceuticals

Phone: (650)243-5555

Email: ngm282@ngmbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place