Trial Outcomes & Findings for Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) (NCT NCT04564339)

Last Updated: 2026-01-22

Results Overview

Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2026-01-22

Participant Flow

For the lupus nephritis (LN) cohort, a total of 57 participants were enrolled in the study and randomized. For the immunoglobulin A nephropathy (IgAN) cohort, a total of 66 participants were enrolled in the study and randomized.

Participant milestones

Participant milestones
Measure	LN Cohort: Ravulizumab Participants with LN received body weight-based loading dose of ravulizumab intravenous (IV) infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then every 8 weeks (q8w) thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).	LN Cohort: Placebo Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).	IgAN Cohort: Ravulizumab Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
Initial Evaluation Period (26 Weeks) STARTED	38	19	43	23
Initial Evaluation Period (26 Weeks) Received at Least 1 Dose of Study Drug	38	19	43	23
Initial Evaluation Period (26 Weeks) COMPLETED	36	18	42	23
Initial Evaluation Period (26 Weeks) NOT COMPLETED	2	1	1	0
Extension Period (Week 26 to Week 50) STARTED	36	18	42	23
Extension Period (Week 26 to Week 50) COMPLETED	34	17	41	23
Extension Period (Week 26 to Week 50) NOT COMPLETED	2	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LN Cohort: Ravulizumab Participants with LN received body weight-based loading dose of ravulizumab intravenous (IV) infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then every 8 weeks (q8w) thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).	LN Cohort: Placebo Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).	IgAN Cohort: Ravulizumab Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
Initial Evaluation Period (26 Weeks) Withdrawal by Subject	1	1	1
Initial Evaluation Period (26 Weeks) Physician Decision	1	0	0
Extension Period (Week 26 to Week 50) Physician Decision	1	0	1
Extension Period (Week 26 to Week 50) Withdrawal by Subject	1	0	0
Extension Period (Week 26 to Week 50) Study Terminated by Sponsor	0	1	0

Baseline Characteristics

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LN Cohort: Ravulizumab n=38 Participants Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).	LN Cohort: Placebo n=19 Participants Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).	IgAN Cohort: Ravulizumab n=43 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=23 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	Total n=123 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=270 Participants	18 Participants n=4 Participants	43 Participants n=9 Participants	22 Participants n=220 Participants	121 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=220 Participants	2 Participants n=3 Participants
Sex: Female, Male Female	27 Participants n=270 Participants	15 Participants n=4 Participants	22 Participants n=9 Participants	8 Participants n=220 Participants	72 Participants n=3 Participants
Sex: Female, Male Male	11 Participants n=270 Participants	4 Participants n=4 Participants	21 Participants n=9 Participants	15 Participants n=220 Participants	51 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=270 Participants	5 Participants n=4 Participants	11 Participants n=9 Participants	3 Participants n=220 Participants	22 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=270 Participants	14 Participants n=4 Participants	27 Participants n=9 Participants	20 Participants n=220 Participants	92 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=270 Participants	0 Participants n=4 Participants	5 Participants n=9 Participants	0 Participants n=220 Participants	9 Participants n=3 Participants
Race/Ethnicity, Customized Race · Asian	13 Participants n=270 Participants	8 Participants n=4 Participants	7 Participants n=9 Participants	7 Participants n=220 Participants	35 Participants n=3 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	7 Participants n=3 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	1 Participants n=3 Participants
Race/Ethnicity, Customized Race · White	14 Participants n=270 Participants	5 Participants n=4 Participants	31 Participants n=9 Participants	16 Participants n=220 Participants	66 Participants n=3 Participants
Race/Ethnicity, Customized Race · Asian, White	1 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	1 Participants n=3 Participants
Race/Ethnicity, Customized Race · Not Reported	3 Participants n=270 Participants	1 Participants n=4 Participants	4 Participants n=9 Participants	0 Participants n=220 Participants	8 Participants n=3 Participants
Race/Ethnicity, Customized Race · Unknown	1 Participants n=270 Participants	2 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	3 Participants n=3 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=270 Participants	1 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=220 Participants	2 Participants n=3 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=41 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=22 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections)	-41.9 percentage change Interval -50.2 to -32.0	-16.8 percentage change Interval -31.8 to 1.6

PRIMARY outcome

Timeframe: Baseline, Week 26

Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=33 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=18 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections)	-69.7 percentage change Interval -79.9 to -54.5	-67.0 percentage change Interval -80.8 to -43.1

SECONDARY outcome

Timeframe: Baseline, Week 50

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=41 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=23 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections)	-44.8 percentage change Interval -55.1 to -32.1	-45.1 percentage change Interval -58.0 to -28.4

SECONDARY outcome

Timeframe: Baseline, Week 50

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=30 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=14 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections)	-77.1 percentage change Interval -86.0 to -62.4	-75.0 percentage change Interval -87.2 to -51.2

SECONDARY outcome

Timeframe: Baseline to Week 26 and Week 50

Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=41 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=23 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 26: >30% Reduction	68.3 percentage of participants Interval 51.9 to 81.9	40.9 percentage of participants Interval 20.7 to 63.6
IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 26: >50% Reduction	43.9 percentage of participants Interval 28.5 to 60.3	18.2 percentage of participants Interval 5.2 to 40.3
IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 50: >30% Reduction	63.4 percentage of participants Interval 46.9 to 77.9	60.9 percentage of participants Interval 38.5 to 80.3
IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 50: >50% Reduction	36.6 percentage of participants Interval 22.1 to 53.1	39.1 percentage of participants Interval 19.7 to 61.5

SECONDARY outcome

Timeframe: Baseline to Week 26 and Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 26: >30% Reduction	50.0 percentage of participants Interval 33.4 to 66.6	73.7 percentage of participants Interval 48.8 to 90.9
LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 26: >50% Reduction	47.4 percentage of participants Interval 31.0 to 64.2	57.9 percentage of participants Interval 33.5 to 79.7
LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 50: >30% Reduction	55.3 percentage of participants Interval 38.3 to 71.4	63.2 percentage of participants Interval 38.4 to 83.7
LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections Week 50: >50% Reduction	52.6 percentage of participants Interval 35.8 to 69.0	47.4 percentage of participants Interval 24.4 to 71.1

SECONDARY outcome

Timeframe: Baseline, Week 26 and Week 50

Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m\^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated a reduction in symptoms.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=42 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=23 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 Change at Week 26	0.22 mL/min/1.73 m^2 Interval -2.3 to 2.74	-4.51 mL/min/1.73 m^2 Interval -7.9 to -1.11
IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 Change at Week 50	-3.87 mL/min/1.73 m^2 Interval -6.41 to -1.33	-6.33 mL/min/1.73 m^2 Interval -9.72 to -2.94

SECONDARY outcome

Timeframe: Baseline, Week 26 and Week 50

Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in mL/min/1.73 m\^2. Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated a reduction in symptoms.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=32 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=17 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Change From Baseline in eGFR at Week 26 and Week 50 Change at Week 26	11.59 mL/min/1.73 m^2 Standard Error 3.38	14.04 mL/min/1.73 m^2 Standard Error 4.56
LN Cohort: Change From Baseline in eGFR at Week 26 and Week 50 Change at Week 50	12.12 mL/min/1.73 m^2 Standard Error 3.49	14.83 mL/min/1.73 m^2 Standard Error 4.86

SECONDARY outcome

Timeframe: Baseline, Week 26 and Week 50

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=42 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=22 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 C3: Change at Week 26	0.027 grams/liter Standard Deviation 0.2389	-0.019 grams/liter Standard Deviation 0.2366
IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 C3: Change at Week 50	-0.001 grams/liter Standard Deviation 0.1902	-0.084 grams/liter Standard Deviation 0.1861
IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 C4: Change at Week 26	-0.005 grams/liter Standard Deviation 0.0576	-0.001 grams/liter Standard Deviation 0.0566
IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 C4: Change at Week 50	-0.006 grams/liter Standard Deviation 0.0510	-0.027 grams/liter Standard Deviation 0.0489

SECONDARY outcome

Timeframe: Baseline, Week 26 and Week 50

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=36 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=17 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 C4: Change at Week 26	0.041 grams/liter Standard Error 0.0775	0.028 grams/liter Standard Error 0.0668
LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 C4: Change at Week 50	0.042 grams/liter Standard Error 0.0887	0.052 grams/liter Standard Error 0.0891
LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 C3: Change at Week 50	0.213 grams/liter Standard Error 0.4783	0.247 grams/liter Standard Error 0.2703
LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 C3: Change at Week 26	0.139 grams/liter Standard Error 0.2414	0.130 grams/liter Standard Error 0.1809

SECONDARY outcome

Timeframe: Week 26 and Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

The CRR was defined as meeting all 3 of the following criteria: - UPCR ≤0.5 gram/gram (g/g); - eGFR \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline; and - no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response (CRR) Week 26	26.3 percentage of participants Interval 13.4 to 43.1	21.1 percentage of participants Interval 6.1 to 45.6
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response (CRR) Week 50	42.1 percentage of participants Interval 26.3 to 59.2	31.6 percentage of participants Interval 12.6 to 56.6

SECONDARY outcome

Timeframe: Week 26 and Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

The PRR was defined as meeting all 3 of the following criteria: - decrease of UPCR \>50% from baseline; - eGFR \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline; and - no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response (PRR) Week 26	15.8 percentage of participants Interval 6.0 to 31.3	36.8 percentage of participants Interval 16.3 to 61.6
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response (PRR) Week 50	10.5 percentage of participants Interval 2.9 to 24.8	10.5 percentage of participants Interval 1.3 to 33.1

SECONDARY outcome

Timeframe: Baseline through Week 50

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=36 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=18 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Time to Urine Protein to Creatinine Ratio (UPCR) < 0.5 g/g, as Measured by Spot Urine Samples	184.0 days Interval 71.0 to Due to insufficient number of participants with response, upper limit of 95% confidence interval (CI) could not be estimated.	295.0 days Interval 128.0 to Due to insufficient number of participants with response, upper limit of 95% CI could not be estimated.

SECONDARY outcome

Timeframe: Week 14, Week 26, and Week 50

A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=18 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 Milligrams (mg)/Day Week 14	84.2 percentage of participants Interval 68.7 to 94.0	94.4 percentage of participants Interval 72.7 to 99.9
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 Milligrams (mg)/Day Week 26	94.4 percentage of participants Interval 81.3 to 99.3	100 percentage of participants Interval 81.5 to 100.0
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 Milligrams (mg)/Day Week 50	76.5 percentage of participants Interval 58.8 to 89.3	82.4 percentage of participants Interval 56.6 to 96.2

SECONDARY outcome

Timeframe: Baseline through Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a CRR, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine \>25% higher than baseline, above the upper limit of normal (plus additional protocol-specified criteria), or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants With Renal Flare	13.2 percentage of participants Interval 4.4 to 28.1	5.3 percentage of participants Interval 0.1 to 26.0

SECONDARY outcome

Timeframe: Baseline through Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assess the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants With Extrarenal Systemic Lupus Erythematosus (SLE) Flare	2.6 percentage of participants Interval 0.1 to 13.8	0.0 percentage of participants Interval 0.0 to 17.6

SECONDARY outcome

Timeframe: Baseline through Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants With Treatment Failure	26.3 percentage of participants Interval 13.4 to 43.1	10.5 percentage of participants Interval 1.3 to 33.1

SECONDARY outcome

Timeframe: Baseline through Week 50

Population: FAS included all randomized participants who received at least 1 dose of the study intervention.

A suboptimal response was to be determined in the opinion of the investigator in addition to the following criterion: reproducible proteinuria ≤25% decreased compared to baseline based on UPCR on a 24-hour urine collection performed by a central laboratory.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=38 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=19 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Percentage of Participants With Suboptimal Response	7.9 percentage of participants Interval 1.7 to 21.4	10.5 percentage of participants Interval 1.3 to 33.1

SECONDARY outcome

Timeframe: Baseline, Week 26, Week 50

For the determination of serum albumin, blood samples were obtained at designated time points.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=35 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=18 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 Change at Week 26	5.14 grams/liter Standard Deviation 5.048	6.94 grams/liter Standard Deviation 5.252
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 Change at Week 50	6.44 grams/liter Standard Deviation 6.761	10.65 grams/liter Standard Deviation 5.408

SECONDARY outcome

Timeframe: Week 26 and Week 50

Partial remission was defined as mean proteinuria \<1 g/24 hours, based on two valid 24-hour urine collections obtained within 2 weeks prior to the study visit.

Outcome measures

Outcome measures
Measure	IgAN Cohort: Ravulizumab n=41 Participants Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	IgAN Cohort: Placebo n=23 Participants Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission Week 50	39.0 percentage of participants Interval 24.2 to 55.5	26.1 percentage of participants Interval 10.2 to 48.4
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission Week 26	26.8 percentage of participants Interval 14.2 to 42.9	18.2 percentage of participants Interval 5.2 to 40.3

Adverse Events

Initial Evaluation Period: LN Cohort - Ravulizumab

Serious events: 6 serious events

Other events: 28 other events

Deaths: 0 deaths

Initial Evaluation Period: LN Cohort - Placebo

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Initial Evaluation Period: IgAN Cohort - Ravulizumab

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Initial Evaluation Period: IgAN Cohort - Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Extension Period: LN Cohort - Ravulizumab to Ravulizumab

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Extension Period: LN Cohort - Placebo to Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Extension Period: IgAN Cohort - Ravulizumab to Ravulizumab

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Extension Period: IgAN Cohort - Placebo to Ravulizumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Initial Evaluation Period: LN Cohort - Ravulizumab n=38 participants at risk Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks).	Initial Evaluation Period: LN Cohort - Placebo n=19 participants at risk Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	Initial Evaluation Period: IgAN Cohort - Ravulizumab n=43 participants at risk Participants with immunoglobulin A nephropathy (IgAN) received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	Initial Evaluation Period: IgAN Cohort - Placebo n=23 participants at risk Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	Extension Period: LN Cohort - Ravulizumab to Ravulizumab n=36 participants at risk Participants continued on the same maintenance regimen (as received during the Initial Evaluation Period) during the Extension Period (24 weeks).	Extension Period: LN Cohort - Placebo to Placebo n=18 participants at risk Participants continued to receive ravulizumab matched placebo q8w until the end of the Extension Period (24 weeks).	Extension Period: IgAN Cohort - Ravulizumab to Ravulizumab n=42 participants at risk Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	Extension Period: IgAN Cohort - Placebo to Ravulizumab n=23 participants at risk Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
Infections and infestations COVID-19	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.3% 1/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Cardiac disorders Cardiac failure acute	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Cellulitis	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Subcutaneous abscess	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Gastroenteritis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Gastroenteritis norovirus	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Tendon rupture	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Seizure	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Depression	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Lupus nephritis	2.6% 1/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Neutropenia	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Bronchitis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Epstein-Barr virus infection reactivation	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Soft tissue infection	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Investigations Hepatic enzyme increased	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Vascular disorders Hypertensive crisis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Initial Evaluation Period: LN Cohort - Ravulizumab n=38 participants at risk Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks).	Initial Evaluation Period: LN Cohort - Placebo n=19 participants at risk Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	Initial Evaluation Period: IgAN Cohort - Ravulizumab n=43 participants at risk Participants with immunoglobulin A nephropathy (IgAN) received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	Initial Evaluation Period: IgAN Cohort - Placebo n=23 participants at risk Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	Extension Period: LN Cohort - Ravulizumab to Ravulizumab n=36 participants at risk Participants continued on the same maintenance regimen (as received during the Initial Evaluation Period) during the Extension Period (24 weeks).	Extension Period: LN Cohort - Placebo to Placebo n=18 participants at risk Participants continued to receive ravulizumab matched placebo q8w until the end of the Extension Period (24 weeks).	Extension Period: IgAN Cohort - Ravulizumab to Ravulizumab n=42 participants at risk Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	Extension Period: IgAN Cohort - Placebo to Ravulizumab n=23 participants at risk Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
Cardiac disorders Palpitations	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Cardiac disorders Pericarditis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Endocrine disorders Cushingoid	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	15.8% 3/19 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Eye disorders Conjunctival haemorrhage	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Eye disorders Optic nerve disorder	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Eye disorders Ulcerative keratitis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Eye disorders Vitreous floaters	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	15.8% 6/38 • Number of events 9 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	9.3% 4/43 • Number of events 5 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	15.8% 6/38 • Number of events 6 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.3% 1/43 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	13.2% 5/38 • Number of events 5 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Mouth ulceration	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Stomatitis	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal distension	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 2/36 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Salivary gland enlargement	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Oedema peripheral	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	15.8% 3/19 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Neutropenia	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Leukopenia	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Pyrexia	10.5% 4/38 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Fatigue	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	7.0% 3/43 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Influenza like illness	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Malaise	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Peripheral swelling	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Non-cardiac chest pain	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Oedema	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
General disorders Vaccination site pain	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Immune system disorders Seasonal allergy	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Nasopharyngitis	10.5% 4/38 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	11.6% 5/43 • Number of events 6 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.3% 3/36 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	14.3% 6/42 • Number of events 6 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations COVID-19	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	9.3% 4/43 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	7.9% 3/38 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	11.1% 2/18 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Influenza	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	4.7% 2/43 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	5.3% 2/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 2/36 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Gastroenteritis viral	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Herpes zoster	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 2/36 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Oral candidiasis	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Oral herpes	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Bacterial infection	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Bronchitis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Conjunctivitis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Fungal foot infection	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Localised infection	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Periodontitis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Immunisation reaction	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	4.7% 2/43 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Investigations Blood magnesium decreased	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Investigations Liver function test increased	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	11.1% 2/18 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	5.3% 2/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	7.9% 3/38 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	7.9% 3/38 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	13.2% 5/38 • Number of events 5 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.3% 3/36 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Sciatica	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Tremor	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Neuropathy peripheral	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Somnolence	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Insomnia	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Anxiety	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Acute kidney injury	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 2/36 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Nephrolithiasis	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Menstruation irregular	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	15.8% 6/38 • Number of events 7 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	10.5% 2/19 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	7.0% 3/43 • Number of events 4 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	2.8% 1/36 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	13.2% 5/38 • Number of events 5 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	13.0% 3/23 • Number of events 7 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Acne	5.3% 2/38 • Number of events 2 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Diffuse alopecia	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Chronic cutaneous lupus erythematosus	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Vascular disorders Raynaud's phenomenon	2.6% 1/38 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/18 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Vascular disorders Essential hypertension	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.
Vascular disorders Hypertension	0.00% 0/38 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/19 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/43 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/36 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	5.6% 1/18 • Number of events 1 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/42 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.	0.00% 0/23 • Baseline up to Week 86 Safety Set included all participants who received at least 1 dose of study intervention.

Additional Information

Alexion Pharmaceuticals, Inc.

Phone: +1-855-752-2356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER