Trial Outcomes & Findings for Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab (NCT NCT05267054)

Last Updated: 2025-09-15

Results Overview

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug(s), whether considered related to study drug(s) or not. An SAE is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement (eg, may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks.

Results posted on

2025-09-15

Participant Flow

The study began in April 2022 and completed in August 2024. Fifty-three participants were enrolled in this study, and all received treatment.

Participant milestones

Participant milestones
Measure	Ociperlimab + Tislelizumab Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Overall Study STARTED	24	29
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	24	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Ociperlimab + Tislelizumab Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Overall Study Death	13	14
Overall Study Study Ended by Sponsor	9	13
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ociperlimab + Tislelizumab n=24 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=29 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Total n=53 Participants Total of all reporting groups
Age, Continuous	64.0 Years n=5 Participants	66.0 Years n=7 Participants	65.0 Years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment China	24 participants n=5 Participants	29 participants n=7 Participants	53 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	59.00 kg n=5 Participants	63.80 kg n=7 Participants	62.00 kg n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks.

Population: The Safety Analysis Set is defined as all participants who received any dose of any study drug(s).

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=24 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=29 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment Emergent Adverse Events	24 Participants	28 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	9 Participants	8 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Safety analysis set

The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33.3%

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=24 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=29 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Recommended Phase 2 Dose (RP2D) of Ociperlimab When Administered in Combination With Tislelizumab or Rituximab	900 mg Q3W	900 mg Q3W

SECONDARY outcome

Timeframe: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Population: Efficacy Analysis Set is defined as all the participants who received any dose of any study drug(s), had evaluable disease at baseline, and had at least one evaluable post-baseline tumor assessment unless clinical progression or death occurred prior to first tumor assessment.

ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) based on the Lugano classification as assessed by the investigator. Response was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDGPET). CR: complete metabolic (no/minimal FDG uptake and no evidence of FDG-avid disease in bone marrow) and radiologic response (target lesions regressed to ≤ 1.5 cm in longest diameter with no extra-lymphatic sites of disease, no organ enlargement and normal bone marrow morphology), no new lesions, and no bone marrow involvement confirmed by bone marrow biopsies (if bone marrow was involved at baseline). PR is partial metabolic (reduced FDG uptake from Baseline) and radiologic response (≥ 50% decrease in size of measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \> 50% in length beyond normal) and no new lesions.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=23 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=27 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Overall Response Rate (ORR)	17.4 percentage of participants Interval 5.0 to 38.8	18.5 percentage of participants Interval 6.3 to 38.1

SECONDARY outcome

Timeframe: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Population: Efficacy analysis set

CRR is defined as the percentage of participants who achieved a complete response per the Lugano Classification (2014) as assessed by the investigator.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=23 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=27 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Complete Response Rate (CRR)	13.0 percentage of participants Interval 2.8 to 33.6	7.4 percentage of participants Interval 0.9 to 24.3

SECONDARY outcome

Timeframe: Up to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Population: Efficacy analysis set; participants with a best overall response of CR or PR.

DOR is defined as the time from the date that response criteria were first met to the date that progressive disease is objectively documented per Lugano Classification (2014), as assessed by the investigator, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=4 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=5 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Duration of Response (DOR)	13.34 Months Interval 6.2 to 18.7	7.82 Months Interval 0.0 to 8.5

SECONDARY outcome

Timeframe: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Population: Efficacy analysis set; participants with a best overall response of CR or PR.

TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) per Lugano Classification (2014) as assessed by the investigator

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=4 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=5 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Time to Response (TTR)	2.09 months Interval 2.07 to 2.17	2.04 months Interval 1.97 to 2.4

SECONDARY outcome

Timeframe: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Population: Efficacy analysis set

PFS is defined as the time from first dose until first documentation of progression per Lugano Classification (2014), as assessed by the investigator, or death, whichever comes first. Median PFS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=23 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=27 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Progression-free Survival (PFS)	1.2 Months Interval 0.9 to 1.9	1.8 Months Interval 0.9 to 2.2

SECONDARY outcome

Timeframe: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.

Population: Efficacy analysis set

OS is defined as the time from first study drug administration to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=23 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=27 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Overall Survival (OS)	13.2 Months Interval 4.4 to Could not be estimated due to insufficient number of events	13.3 Months Interval 4.9 to Could not be estimated due to insufficient number of events

SECONDARY outcome

Timeframe: Predose and end of infusion (EOI) on Cycle 1 Day 1 (C1D1), Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, and Cycle 17 Day 1

Population: Pharmacokinetic (PK) analysis set includes all participants who received any dose of study drug(s), for whom any quantifiable postdose PK concentrations were available. Results are reported for participants with available data at each time point.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=24 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=29 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Serum Concentration of Ociperlimab Predose C1D1	NA μg/mL Geometric Coefficient of Variation NA Could not be estimated as no participants with measurable concentrations.	NA μg/mL Geometric Coefficient of Variation NA Could not be estimated as no participants with measurable concentrations.
Serum Concentration of Ociperlimab EOI C1D1	323.96 μg/mL Geometric Coefficient of Variation 21.810	296.48 μg/mL Geometric Coefficient of Variation 18.832
Serum Concentration of Ociperlimab Predose C2D1	61.84 μg/mL Geometric Coefficient of Variation 36.832	63.68 μg/mL Geometric Coefficient of Variation 38.413
Serum Concentration of Ociperlimab EOI C2D1	371.62 μg/mL Geometric Coefficient of Variation 24.589	389.27 μg/mL Geometric Coefficient of Variation 18.555
Serum Concentration of Ociperlimab Predose C5D1	127.20 μg/mL Geometric Coefficient of Variation 45.138	184.09 μg/mL Geometric Coefficient of Variation 27.675
Serum Concentration of Ociperlimab EOI C5D1	450.52 μg/mL Geometric Coefficient of Variation 10.707	507.48 μg/mL Geometric Coefficient of Variation 15.295
Serum Concentration of Ociperlimab Predose C9D1	181.58 μg/mL Geometric Coefficient of Variation 46.927	184.83 μg/mL Geometric Coefficient of Variation 23.101
Serum Concentration of Ociperlimab Predose C17D1	320.00 μg/mL	—

SECONDARY outcome

Timeframe: From first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks

Population: The Immunogenicity Analysis Set is defined as all participants who received any dose of any study drug(s), for whom both Baseline ADA and ≥ 1 postbaseline ADA results were available.

The number of participants with anti-drug antibodies to ociperlimab includes participants that were ADA-negative at Baseline and ADA-positive after drug administration during the treatment or follow-up observation period and participants who were positive at Baseline for ADA and with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period.

Outcome measures

Outcome measures
Measure	Ociperlimab + Tislelizumab n=19 Participants Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=24 Participants Participants received ociperlimab 900 mg and rituximab 375 mg/m\^2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Host Immunogenicity: Number of Participants With Anti-drug Antibodies (ADA) to Ociperlimab	0 Participants	1 Participants

Adverse Events

Ociperlimab + Tislelizumab

Serious events: 9 serious events

Other events: 23 other events

Deaths: 13 deaths

Ociperlimab + Rituximab

Serious events: 8 serious events

Other events: 28 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: 1 877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ociperlimab + Tislelizumab n=24 participants at risk Participants received ociperlimab 900 mg and tislelizumab 200 mg every three weeks (Q3W) by intravenous injection (IV) until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.	Ociperlimab + Rituximab n=29 participants at risk Participants received ociperlimab 900 mg and rituximab 375 mg/m2 Q3W by intravenous injection until confirmed progressive disease, death, withdrawal of consent, loss of follow-up, or the end of study.
Blood and lymphatic system disorders Anaemia	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Blood and lymphatic system disorders Febrile neutropenia	4.2% 1/24 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Cardiac disorders Cardiac failure	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 2 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
General disorders Death	4.2% 1/24 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
General disorders Oedema peripheral	4.2% 1/24 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Infections and infestations Bacteraemia	4.2% 1/24 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Infections and infestations Herpes zoster	4.2% 1/24 • Number of events 3 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Infections and infestations Oral infection	4.2% 1/24 • Number of events 2 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Infections and infestations Pneumonia	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Infections and infestations Respiratory tract infection	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 3 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Investigations Neutrophil count decreased	4.2% 1/24 • Number of events 3 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 1 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 2 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 3 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/24 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	3.4% 1/29 • Number of events 2 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.
Vascular disorders Shock	4.2% 1/24 • Number of events 2 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.	0.00% 0/29 • All-cause mortality was assessed from enrollment through the end of the study, maximum time on study was 28 months. Adverse events were assessed from first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks.