Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors (NCT NCT04434092)

NCT ID: NCT04434092

Last Updated: 2025-11-10

Results Overview

TA is defined as participants who are packed red blood cell (pRBC) transfusion-free and do not require transfusion per protocol-specified guidelines. 95% Confidence Interval (CI) for percentage of participants with TA was calculated using the Wilson's method with continuity correction. Participants who withdrew before Week 25 were deemed to have had a transfusion. Percentages are rounded off to the nearest single decimal.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 210 participants
• Primary outcome timeframe: Baseline to Week 25
• Results posted on: 2025-11-10

Participant Flow

Participants were enrolled at centres in Argentina, Brazil, China, France, Greece, Germany, Hong Kong, Japan, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania Republic of Korea, Singapore, Spain, Sweden, Thailand, Türkiye, Taiwan, Ukraine, and United Kingdom from 08 Oct 2020 to 16 Nov 2022. The study is ongoing.

A total of 204 participants who were diagnosed with paroxysmal nocturnal hemoglobinuria (PNH) and who had not been previously treated with a complement-inhibitor therapy were randomized in a ratio of 2:1, 135 to crovalimab (Arm A) and 69 to eculizumab (Arm B). 6 paediatric participants were enrolled into non-randomized crovalimab (Arm C).

Participant milestones

Measure	Arm A: Crovalimab Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.	Arm C: Crovalimab Pediatric participants received initial loading dose of 1000 mg (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight \>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) Q4W from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.
Primary Treatment Period:Baseline-Week24 STARTED	135	69	6
Primary Treatment Period:Baseline-Week24 COMPLETED	129	68	6
Primary Treatment Period:Baseline-Week24 NOT COMPLETED	6	1	0
Extension Treatment Period:Week 25-5 Yrs STARTED	129	68	6
Extension Treatment Period:Week 25-5 Yrs COMPLETED	0	0	0
Extension Treatment Period:Week 25-5 Yrs NOT COMPLETED	129	68	6

Reasons for withdrawal

Measure	Arm A: Crovalimab Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.	Arm C: Crovalimab Pediatric participants received initial loading dose of 1000 mg (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight \>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) Q4W from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.
Primary Treatment Period:Baseline-Week24 Physician Decision	2	0	0
Primary Treatment Period:Baseline-Week24 Withdrawal by Subject	2	0	0
Primary Treatment Period:Baseline-Week24 Lost to Follow-up	1	0	0
Primary Treatment Period:Baseline-Week24 Death	1	1	0
Extension Treatment Period:Week 25-5 Yrs Treatment (Crovalimab) Ongoing	127	65	6
Extension Treatment Period:Week 25-5 Yrs Withdrawal by Subject	2	2	0
Extension Treatment Period:Week 25-5 Yrs Adverse Event	0	1	0

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Baseline characteristics by cohort

Measure	Arm A: Crovalimab n=135 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.	Arm C: Crovalimab n=6 Participants Pediatric participants received initial loading dose of 1000 mg (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight \>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) Q4W from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Total n=210 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	2 Participants n=20 Participants	6 Participants n=40 Participants	8 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	58 Participants n=20 Participants	0 Participants n=40 Participants	180 Participants n=28 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	9 Participants n=20 Participants	0 Participants n=40 Participants	22 Participants n=28 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	34 Participants n=20 Participants	2 Participants n=40 Participants	94 Participants n=28 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	35 Participants n=20 Participants	4 Participants n=40 Participants	116 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	6 Participants n=20 Participants	1 Participants n=40 Participants	25 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=5 Participants	61 Participants n=20 Participants	5 Participants n=40 Participants	180 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	5 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	86 Participants n=5 Participants	51 Participants n=20 Participants	5 Participants n=40 Participants	142 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	4 Participants n=28 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	16 Participants n=20 Participants	0 Participants n=40 Participants	61 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	3 Participants n=28 Participants

PRIMARY outcome

Timeframe: Baseline to Week 25

Population: Primary Analysis Population (PAP) included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid lactate dehydrogenase (LDH) level assessment by the central laboratory after the first IV infusion by planned treatment.

TA is defined as participants who are packed red blood cell (pRBC) transfusion-free and do not require transfusion per protocol-specified guidelines. 95% Confidence Interval (CI) for percentage of participants with TA was calculated using the Wilson's method with continuity correction. Participants who withdrew before Week 25 were deemed to have had a transfusion. Percentages are rounded off to the nearest single decimal.

Outcome measures

Measure	Arm A: Crovalimab n=134 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Percentage of Participants With Transfusion Avoidance (TA)	65.7 percentage of participants Interval 56.91 to 73.52	68.1 percentage of participants Interval 55.67 to 78.53

PRIMARY outcome

Timeframe: Week 5 to Week 25

Population: PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment.

A Generalized Estimating Equation (GEE) was used to estimate the population-average percentage of the participants with hemolysis control (measured by LDH ≤1.5 x upper limit of normal (ULN)) from Week 5 to Week 25 taking account of the intra-patient and inter-patient correlation between LDH control statuses across visits. Percentages are rounded off to the nearest single decimal.

Outcome measures

Measure	Arm A: Crovalimab n=134 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Percentage of Participants With Hemolysis Control Measured by LDH	79.3 percentage of participants Interval 72.86 to 84.48	79.0 percentage of participants Interval 69.66 to 85.99

SECONDARY outcome

Timeframe: Baseline to Week 25

Population: PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment.

BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin < 10 grams per deciliter (g/dL)], major adverse vascular event [MAVE, including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2xULN after a prior LDH reduction to ≤1.5xULN from the start of study treatment. 95% CI for percentage of participants with BTH was calculated using the Wilson's method with continuity correction. Participants who withdrew before Week 25 were deemed to have experienced a BTH event. Percentages are rounded off to the nearest single decimal.

Outcome measures

Measure	Arm A: Crovalimab n=134 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Percentage of Participants With Breakthrough Hemolysis (BTH)	10.4 percentage of participants Interval 6.04 to 17.21	14.5 percentage of participants Interval 7.54 to 25.5

SECONDARY outcome

Timeframe: Baseline to Week 25

Population: PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment.

Stabilized hemoglobin is defined as avoidance of a >= 2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion. 95% CI for percentage of participants with stabilized hemoglobin was calculated using the Wilson's method with continuity correction. Participants who withdrew before Week 25 were deemed to not have had hemoglobin stabilization. Percentages are rounded off to the nearest single decimal.

Outcome measures

Measure	Arm A: Crovalimab n=134 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Percentage of Participants With Stabilization of Hemoglobin	63.4 percentage of participants Interval 54.63 to 71.45	60.9 percentage of participants Interval 48.35 to 72.17

SECONDARY outcome

Timeframe: Baseline to Week 25

Population: PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Fatigue was assessed using FACIT-F scale. FACIT-F is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Items are scored on a response scale that ranges from 0 ("not at all") to 4 ("very much so"). Relevant items are reverse scored, and all the items are summed to create a total score range from 0 to 52, with 0 being the worst possible score and 52 being the best possible score. A higher score indicates low fatigue severity. A positive mean change indicates improvement. FACIT-F was assessed in adult participants only.

Outcome measures

Measure	Arm A: Crovalimab n=134 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=67 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Change From Baseline in Fatigue Assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Baseline	36.02 score on scale Standard Error 0.877	35.09 score on scale Standard Error 1.408
Change From Baseline in Fatigue Assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Change at Week 25	7.79 score on scale Standard Error 0.661	5.15 score on scale Standard Error 0.880

SECONDARY outcome

Timeframe: Up to 6 years

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Injection-site reactions or infusion-related reaction are AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 1 Week 1, Week 2, 3, 4, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 and 25

Population: Randomized Safety Population includes all randomized participants who have received at least one dose of study treatment. Includes only participants from Arms A and B. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Outcome measures

Measure	Arm A: Crovalimab n=79 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=35 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Change From Baseline in Absolute Reticulocyte Count Change at Week 17	1929.82 10^9 cells/liter (L) Standard Deviation 15576.37	33.22 10^9 cells/liter (L) Standard Deviation 73.34
Change From Baseline in Absolute Reticulocyte Count Change at Week 19	62.91 10^9 cells/liter (L) Standard Deviation 390.39	22.16 10^9 cells/liter (L) Standard Deviation 70.68
Change From Baseline in Absolute Reticulocyte Count Change at Week 21	633.95 10^9 cells/liter (L) Standard Deviation 4919.97	15.90 10^9 cells/liter (L) Standard Deviation 72.72
Change From Baseline in Absolute Reticulocyte Count Change at Week 23	698.79 10^9 cells/liter (L) Standard Deviation 5409.05	27.51 10^9 cells/liter (L) Standard Deviation 85.87
Change From Baseline in Absolute Reticulocyte Count Change at Week 25	1396.46 10^9 cells/liter (L) Standard Deviation 11622.57	32.31 10^9 cells/liter (L) Standard Deviation 97.79
Change From Baseline in Absolute Reticulocyte Count Change at Week 3	-71.08 10^9 cells/liter (L) Standard Deviation 533.01	-15.62 10^9 cells/liter (L) Standard Deviation 53.79
Change From Baseline in Absolute Reticulocyte Count Change at Week 4	8.52 10^9 cells/liter (L) Standard Deviation 58.01	-10.56 10^9 cells/liter (L) Standard Deviation 51.36
Change From Baseline in Absolute Reticulocyte Count Change at Week 5	-1126.63 10^9 cells/liter (L) Standard Deviation 9074.19	4.85 10^9 cells/liter (L) Standard Deviation 49.43
Change From Baseline in Absolute Reticulocyte Count Change at Week 7	-3517.66 10^9 cells/liter (L) Standard Deviation 26606.21	7020.33 10^9 cells/liter (L) Standard Deviation 38344.72
Change From Baseline in Absolute Reticulocyte Count Change at Week 9	12.60 10^9 cells/liter (L) Standard Deviation 62.05	20.65 10^9 cells/liter (L) Standard Deviation 60.04
Change From Baseline in Absolute Reticulocyte Count Change at Week 11	425.66 10^9 cells/liter (L) Standard Deviation 3343.99	26.12 10^9 cells/liter (L) Standard Deviation 81.80
Change From Baseline in Absolute Reticulocyte Count Change at Week 13	24.47 10^9 cells/liter (L) Standard Deviation 48.92	28.61 10^9 cells/liter (L) Standard Deviation 78.48
Change From Baseline in Absolute Reticulocyte Count Change at Week 15	-838.52 10^9 cells/liter (L) Standard Deviation 6735.13	37.20 10^9 cells/liter (L) Standard Deviation 77.52
Change From Baseline in Absolute Reticulocyte Count Baseline	2865.56 10^9 cells/liter (L) Standard Deviation 22637.24	164.26 10^9 cells/liter (L) Standard Deviation 114.27
Change From Baseline in Absolute Reticulocyte Count Change at Week 1 Day 1	-58.50 10^9 cells/liter (L) Standard Deviation NA The standard deviation was not estimable due to low number of participants	—
Change From Baseline in Absolute Reticulocyte Count Change at Week 2	542.90 10^9 cells/liter (L) Standard Deviation 4314.07	105.88 10^9 cells/liter (L) Standard Deviation 601.77

SECONDARY outcome

Timeframe: Baseline, Week 2, 3, 4, 5, 9, 13, 17, 21, and 25

Population: Randomized Safety Population includes all randomized participants who have received at least one dose of study treatment. Includes only participants from Arms A and B. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Outcome measures

Measure	Arm A: Crovalimab n=84 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=42 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Change From Baseline in Free Hemoglobin Baseline	474.88 milligram per litre (mg)/L Standard Deviation 276.49	495.69 milligram per litre (mg)/L Standard Deviation 393.56
Change From Baseline in Free Hemoglobin Change at Week 2	-406.39 milligram per litre (mg)/L Standard Deviation 273.33	-407.10 milligram per litre (mg)/L Standard Deviation 339.84
Change From Baseline in Free Hemoglobin Change at Week 3	-409.10 milligram per litre (mg)/L Standard Deviation 286.35	-393.20 milligram per litre (mg)/L Standard Deviation 352.22
Change From Baseline in Free Hemoglobin Change at Week 4	-413.16 milligram per litre (mg)/L Standard Deviation 281.40	-418.00 milligram per litre (mg)/L Standard Deviation 441.01
Change From Baseline in Free Hemoglobin Change at Week 5	-386.62 milligram per litre (mg)/L Standard Deviation 424.67	-421.14 milligram per litre (mg)/L Standard Deviation 402.64
Change From Baseline in Free Hemoglobin Change at Week 9	-404.29 milligram per litre (mg)/L Standard Deviation 298.64	-405.89 milligram per litre (mg)/L Standard Deviation 425.73
Change From Baseline in Free Hemoglobin Change at Week 17	-408.15 milligram per litre (mg)/L Standard Deviation 285.24	-340.00 milligram per litre (mg)/L Standard Deviation 503.24
Change From Baseline in Free Hemoglobin Change at Week 21	-367.86 milligram per litre (mg)/L Standard Deviation 341.53	-387.63 milligram per litre (mg)/L Standard Deviation 462.10
Change From Baseline in Free Hemoglobin Change at Week 25	-431.50 milligram per litre (mg)/L Standard Deviation 277.83	-334.96 milligram per litre (mg)/L Standard Deviation 516.40
Change From Baseline in Free Hemoglobin Change at Week 13	-409.94 milligram per litre (mg)/L Standard Deviation 298.14	-328.56 milligram per litre (mg)/L Standard Deviation 586.25

SECONDARY outcome

Timeframe: Baseline, Week 2, 3, 4, 5, 9, 13, 15, 17, 21, and 25

Population: Randomized Safety Population includes all randomized participants who have received at least one dose of study treatment. Includes only participants from Arms A and B. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Outcome measures

Measure	Arm A: Crovalimab n=85 Participants Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=42 Participants Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.
Change From Baseline in Haptoglobin Baseline	0.05 gram (g)/L Standard Deviation 0.00	0.05 gram (g)/L Standard Deviation 0.00
Change From Baseline in Haptoglobin Change at Week 2	0.05 gram (g)/L Standard Deviation 0.14	0.08 gram (g)/L Standard Deviation 0.19
Change From Baseline in Haptoglobin Change at Week 3	0.05 gram (g)/L Standard Deviation 0.16	0.11 gram (g)/L Standard Deviation 0.28
Change From Baseline in Haptoglobin Change at Week 4	0.08 gram (g)/L Standard Deviation 0.21	0.12 gram (g)/L Standard Deviation 0.28
Change From Baseline in Haptoglobin Change at Week 5	0.06 gram (g)/L Standard Deviation 0.16	0.09 gram (g)/L Standard Deviation 0.23
Change From Baseline in Haptoglobin Change at Week 9	0.05 gram (g)/L Standard Deviation 0.17	0.07 gram (g)/L Standard Deviation 0.23
Change From Baseline in Haptoglobin Change at Week 13	0.04 gram (g)/L Standard Deviation 0.17	0.06 gram (g)/L Standard Deviation 0.21
Change From Baseline in Haptoglobin Change at Week 17	0.05 gram (g)/L Standard Deviation 0.16	0.05 gram (g)/L Standard Deviation 0.14
Change From Baseline in Haptoglobin Change at Week 21	0.06 gram (g)/L Standard Deviation 0.18	0.06 gram (g)/L Standard Deviation 0.22
Change From Baseline in Haptoglobin Change at Week 25	0.06 gram (g)/L Standard Deviation 0.17	0.05 gram (g)/L Standard Deviation 0.21

Adverse Events

Arm A: Crovalimab

Serious events: 22 serious events

Other events: 102 other events

Deaths: 2 deaths

Arm B: Eculizumab

Serious events: 14 serious events

Other events: 55 other events

Deaths: 1 deaths

Arm C: Crovalimab

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: Crovalimab n=135 participants at risk Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 participants at risk Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.	Arm C: Crovalimab n=6 participants at risk Pediatric participants received initial loading dose of 1000 mg (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight \>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) Q4W from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.
Blood and lymphatic system disorders Anaemia	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Blood and lymphatic system disorders Aplastic anaemia	1.5% 2/135 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Blood and lymphatic system disorders Breakthrough haemolysis	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Blood and lymphatic system disorders Thrombocytopenia	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Cardiac disorders Cardiac failure	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Cardiac disorders Coronary artery disease	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Cardiac disorders Myocardial infarction	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Gastrointestinal disorders Small intestinal haemorrhage	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
General disorders Pyrexia	0.74% 1/135 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Hepatobiliary disorders Cholelithiasis	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations COVID-19	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Central nervous system infection	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Dengue fever	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Gastroenteritis	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Infection	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Influenza	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Pneumonia	3.0% 4/135 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Pyelonephritis	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Sepsis	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Septic shock	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Tuberculosis	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Upper respiratory tract infection	1.5% 2/135 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Urinary tract infection	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Injury, poisoning and procedural complications Infusion related reaction	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Injury, poisoning and procedural complications Limb traumatic amputation	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Nervous system disorders Ischaemic stroke	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Nervous system disorders Seizure	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Psychiatric disorders Affective disorder	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Renal and urinary disorders Paroxysmal nocturnal haemoglobinuria	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 2/135 • Number of events 3 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Vascular disorders Hypovolaemic shock	0.74% 1/135 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).

Other adverse events

Measure	Arm A: Crovalimab n=135 participants at risk Crovalimab was administered at an initial loading dose of 1000 milligram (mg) (for participants with body weight between 40 and 100 kilogram (kg)) or 1500 mg (for participants with body weight \>=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) once every 4 weeks (Q4W) from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.	Arm B: Eculizumab n=69 participants at risk Participants received loading doses of eculizumab 600 mg IV on Days 1, 8, 15, and 22, followed by maintenance doses of 900 mg IV on Day 29 and every 2 weeks (Q2W) thereafter up to Week 24 in the primary treatment period. Participants who switched to crovalimab received crovalimab as an IV loading dose of 1000 mg (if body weight was between 40 kg to \<100 kg) or 1500 mg (if body weight was \>=100kg) on Week 25 Day 1, 340 mg SC on Week 25 Day 2, then 340 mg SC QW on Weeks 26, 27, 28, followed by crovalimab maintenance dose of 680 mg SC (if body weight was between 40 kg to \<100 kg) or 1020 mg SC (if body weight was \>=100kg) on Week 29 and Q4W thereafter up to a maximum of 5 years in the extension treatment period.	Arm C: Crovalimab n=6 participants at risk Pediatric participants received initial loading dose of 1000 mg (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight \>=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight \>=100kg) Q4W from Week 5 until 24 weeks in primary treatment period. After Week 24, participants continued to receive maintenance dose of crovalimab up to a maximum of 5 years in the extension treatment period.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/69 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Gastrointestinal disorders Diarrhoea	8.1% 11/135 • Number of events 12 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	2.9% 2/69 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
General disorders Fatigue	3.0% 4/135 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	4.3% 3/69 • Number of events 3 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
General disorders Pyrexia	11.1% 15/135 • Number of events 18 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	11.6% 8/69 • Number of events 11 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Immune system disorders Type III immune complex mediated reaction	0.00% 0/135 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	15.9% 11/69 • Number of events 12 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations COVID-19	20.7% 28/135 • Number of events 28 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	13.0% 9/69 • Number of events 9 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Upper respiratory tract infection	12.6% 17/135 • Number of events 21 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	15.9% 11/69 • Number of events 14 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Infections and infestations Urinary tract infection	3.7% 5/135 • Number of events 8 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	7.2% 5/69 • Number of events 5 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Injury, poisoning and procedural complications Contusion	1.5% 2/135 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Injury, poisoning and procedural complications Infusion related reaction	14.8% 20/135 • Number of events 21 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	14.5% 10/69 • Number of events 12 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Injury, poisoning and procedural complications Injection related reaction	5.2% 7/135 • Number of events 7 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	5.8% 4/69 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Investigations Alanine aminotransferase increased	3.0% 4/135 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	5.8% 4/69 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Investigations Neutrophil count decreased	13.3% 18/135 • Number of events 45 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	11.6% 8/69 • Number of events 15 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Investigations White blood cell count decreased	12.6% 17/135 • Number of events 46 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	14.5% 10/69 • Number of events 29 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Metabolism and nutrition disorders Hyperuricaemia	8.1% 11/135 • Number of events 17 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	10.1% 7/69 • Number of events 17 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	33.3% 2/6 • Number of events 3 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Metabolism and nutrition disorders Hypocalcaemia	5.9% 8/135 • Number of events 12 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	10.1% 7/69 • Number of events 16 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Metabolism and nutrition disorders Hypokalaemia	11.1% 15/135 • Number of events 34 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	13.0% 9/69 • Number of events 25 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Metabolism and nutrition disorders Hypomagnesaemia	2.2% 3/135 • Number of events 8 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	1.4% 1/69 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 5/135 • Number of events 5 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	5.8% 4/69 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Nervous system disorders Dizziness	2.2% 3/135 • Number of events 4 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	5.8% 4/69 • Number of events 13 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Nervous system disorders Headache	9.6% 13/135 • Number of events 17 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	8.7% 6/69 • Number of events 9 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	16.7% 1/6 • Number of events 1 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).
Respiratory, thoracic and mediastinal disorders Cough	5.2% 7/135 • Number of events 8 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	2.9% 2/69 • Number of events 2 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).	0.00% 0/6 • From randomization until primary completion date cutoff (up to approximately 25 weeks) Data collected up to 25 weeks are reported here. Adverse event data collection for the Extension Treatment Period is ongoing and will be reported one year after the study completion date. All Participant Population includes all participant enrolled to the originally assigned treatment arms (Arms A, B and C).

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER