Trial Outcomes & Findings for A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205] (NCT NCT05179603)

Last Updated: 2025-12-24

Results Overview

The CRR was defined as the percentage of participants who had a complete response (CR) as the best overall response (BOR) as per Investigator assessment (Lugano response criteria 2014). The BOR was defined as the BOR observed from the date of first study treatment until PD, death, cut-off date or initiation of subsequent anti-cancer therapy, whichever occurred first. CR based on computed tomography (CT)-based response: lymph nodes and extralymphatic sites with target nodes/nodal masses must regress to \<=1.5 centimeter (cm) in longest transverse diameter of a lesion (LDi) and no extralymphatic sites of disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

From first dose of study treatment administration (Day 1) up to approximately 21 months

Results posted on

2025-12-24

Participant Flow

This study was conducted at 7 centers (corresponds to number of sites which screened at least one participant) in 3 countries from 07 December 2021 to 26 October 2022. Out of 19 participants who were screened, 14 participants were enrolled in the study.

The study was terminated based on strategic sponsor decision not driven by any safety concerns. The Cohort C1 was not initiated and no participants were enrolled. Note: Reason for not completed = Reason for permanent full intervention discontinuation.

Participant milestones

Participant milestones
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab Participants with classic Hodgkin lymphoma (cHL) who were anti-programmed cell death-ligand 1 (PD-L1)-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 microgram per kilogram (μg/kg) via intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 milligram (mg) via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as third-line or fourth-line (3/4L) therapy, until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Overall Study STARTED	14
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab Participants with classic Hodgkin lymphoma (cHL) who were anti-programmed cell death-ligand 1 (PD-L1)-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 microgram per kilogram (μg/kg) via intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 milligram (mg) via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as third-line or fourth-line (3/4L) therapy, until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Overall Study Unspecified: Not related to Coronavirus Disease 2019 (COVID-19)	3
Overall Study Withdrawal by Subject	1
Overall Study Progressive disease	4
Overall Study Adverse event: Not related to COVID-19	4

Baseline Characteristics

A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Age, Continuous	29.6 years STANDARD_DEVIATION 6.0 • n=30 Participants
Sex: Female, Male Female	10 Participants n=30 Participants
Sex: Female, Male Male	4 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants
Race (NIH/OMB) White	14 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to approximately 21 months

Population: The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Complete Response Rate (CRR)	71.4 percentage of participants Interval 46.0 to 89.6

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 28 months

ORR was defined as the percentage of the participants with CR or partial response (PR) as the BOR as per Investigator assessment (Lugano response criteria 2014). The BOR was defined as the BOR observed from the date of first study treatment until PD, death, cut-off date or initiation of subsequent anti-cancer therapy, whichever occurs first. CR (CT-based response): lymph nodes and extralymphatic sites with target nodes/nodal masses must regress to \<=1.5cm in LDi and no extralymphatic sites of disease. PR (CT-based response): lymph nodes and extralymphatic sites with \>=50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of upto 6 target measurable nodes and extranodal sites. A lesion too small to measure on CT, 5 millimeter (mm) X 5mm used as default value. No longer visible, 0 X 0 mm. A node \>5mm X 5mm, but smaller than normal, actual measurement used.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Objective Response Rate (ORR)	92.9 percentage of participants Interval 70.3 to 99.6

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 29 months

Population: The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the Investigator's opinion) or became serious during the TE period.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	14 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days)

Population: DLT-evaluable population consisted of all exposed participants in safety run-in part who had been treated and observed for DLT observation period. Any participants who had experienced a DLT during DLT observation period were also DLT-evaluable.

Selected events that occurred during the DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: grade 4 neutropenic fever, grade 4 thrombocytopenia associated with clinically significant bleeding that required clinical intervention, grade 3 or above alanine aminotransferase or aspartate aminotransferase in combination with a bilirubin \>2 × upper limit of normal with no evidence of cholestasis or another cause, such as viral infection or other drugs, grade 3 or above vascular leak syndrome, grade 3 or above hypotension, grade 3 or above cytokine release syndrome, grade 3 or above AE that did not resolve to grade \<=2 within 7 days of starting accepted standard of care medical management.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=7 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Number of Participants With Dose Limiting Toxicities (DLTs)	1 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 28 months

The TTR was defined as the time from the first administration of study treatment to the first tumor assessment at which the overall response was recorded as PR or CR determined by Investigator (Lugano response criteria 2014). CR (CT-based response): lymph nodes and extralymphatic sites with target nodes/nodal masses must regress to \<=1.5cm in LDi and no extralymphatic sites of disease. PR (CT-based response): lymph nodes and extralymphatic sites with \>=50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of upto 6 target measurable nodes and extranodal sites. A lesion too small to measure on CT, 5 millimeter (mm) X 5mm used as default value. No longer visible, 0 X 0 mm. A node \>5mm X 5mm, but smaller than normal, actual measurement used.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=13 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Time to Response (TTR)	2.0 months Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 28 months

The DoR was defined as the time from the first tumor assessment at which the overall response was recorded as PR or CR until PD determined by Investigator (Lugano response criteria 2014), or death from any cause, whichever occurred first. CR (CT-based response): lymph nodes and extralymphatic sites with target nodes/nodal masses must regress to \<=1.5cm in LDi and no extralymphatic sites of disease. PR (CT-based response): lymph nodes and extralymphatic sites with \>=50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of upto 6 target measurable nodes and extranodal sites. A lesion too small to measure on CT, 5 millimeter (mm) X 5mm used as default value. No longer visible, 0 X 0 mm. A node \>5mm X 5mm, but smaller than normal, actual measurement used.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=13 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Duration of Response (DoR)	NA months Interval 6.3 to NA indicates that the median and upper limit of 90% confidence interval (CI) were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 28 months

CBR was defined as percentage of participants with clinical benefit (CR or PR as BOR, or stable disease \[SD\] lasting at least 6 months) determined by Investigator per Lugano response criteria 2014. BOR was defined as BOR observed from date of first study treatment until PD, death, cut-off date or initiation of subsequent anti-cancer therapy, whichever occurred first. CR (CT-based response): lymph nodes and extralymphatic sites with target nodes/nodal masses must regress to \<=1.5cm in LDi and no extralymphatic sites of disease. PR (CT-based response): lymph nodes and extralymphatic sites with \>=50% decrease in SPD of upto 6 target measurable nodes and extranodal sites. A lesion too small to measure on CT, 5mm X 5mm used as default value. No longer visible, 0 X 0 mm. A node \>5mm X 5mm, but smaller than normal, actual measurement used. SD (CT-based response): \<50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extranodal sites; no criteria for PD met.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Clinical Benefit Rate (CBR)	92.9 percentage of participants Interval 70.3 to 99.6

SECONDARY outcome

Timeframe: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 28 months

The PFS was defined as the time from the date of first study treatment administration to the date of the first documented PD determined by Investigator (Lugano response criteria 2014), or death due to any cause. PFS (CT-based response): An individual node/lesion had to be abnormal with: LDi \>1.5 cm and increased by \>=50% from positron emission tomography nadir and an increase in LDi or shortest axis perpendicular to the LDi from nadir, 0.5cm for lesions \<=2 cm, 1.0cm for lesions\>2 cm. In the setting of splenomegaly, the splenic length must be increased by \>50% of the extent of its prior increase beyond baseline. If there was no prior splenomegaly, increase by at least 2 cm from baseline. For new lesions regrowth of previously resolved lesions: a new node \>1.5 cm in any axis, a new extranodal site\>1.0 cm in any axis.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Progression Free Survival (PFS)	NA months Interval 8.3 to NA indicates that the median and upper limit of 90% CI were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Cycle 1 Day 2, Cycle 1 Day 3 (each cycle is 21 days)

Population: The pharmacokinetic (PK) population consisted of all participants from the exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported.

Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin .

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=9 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Plasma Concentrations of Pegenzileukin Cycle 1 Day 2	191.7 nanogram/milliliter (ng/mL) Standard Deviation 78.4
Plasma Concentrations of Pegenzileukin Cycle 1 Day 3	95.2 nanogram/milliliter (ng/mL) Standard Deviation 75.8

SECONDARY outcome

Timeframe: Cycles 1, 2, 4, 7, 10, 15 (each cycle is 21 days)

Population: The PK population consisted of all participants from the exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported.

Blood samples were collected at specified timepoints for the assessment of Ceoi of pegenzileukin .

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=13 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Concentration at End of Infusion (Ceoi) of Pegenzileukin Cycle 2	405.4 ng/mL Standard Deviation 255.6
Concentration at End of Infusion (Ceoi) of Pegenzileukin Cycle 4	435.2 ng/mL Standard Deviation 173.9
Concentration at End of Infusion (Ceoi) of Pegenzileukin Cycle 1	438.2 ng/mL Standard Deviation 238.6
Concentration at End of Infusion (Ceoi) of Pegenzileukin Cycle 7	594.7 ng/mL Standard Deviation 208.4
Concentration at End of Infusion (Ceoi) of Pegenzileukin Cycle 10	596.3 ng/mL Standard Deviation 181.3
Concentration at End of Infusion (Ceoi) of Pegenzileukin Cycle 15	325.0 ng/mL Standard Deviation NA NA indicates that the standard deviation (SD) was not estimable for 1 participant.

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 29 months

Population: ADA population consisted of all participants from exposed population with at least one ADA result (positive, negative or inconclusive) after the first dose of study treatment.

Blood samples were collected at specified timepoints to assess the presence of ADA against pegenzileukin . Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.

Outcome measures

Outcome measures
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=12 Participants Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Number of Participants With Anti-Drug Antibodies (ADA) Against Pegenzileukin	3 Participants

Adverse Events

Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 participants at risk Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Infections and infestations Septic Shock	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Urinary Tract Infection Fungal	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Immune system disorders Cytokine Release Syndrome	21.4% 3/14 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Endocrine disorders Hypophysitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Endocrine disorders Immune-Mediated Hypophysitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Cardiac disorders Immune-Mediated Myocarditis	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Hepatobiliary disorders Immune-Mediated Hepatitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.

Other adverse events

Other adverse events
Measure	Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab n=14 participants at risk Participants with cHL who were anti-PD-L1-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 μg/kg via IV infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 mg via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as 3/4L therapy, until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Infections and infestations Bronchitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Dengue Fever	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Nasopharyngitis	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Oral Herpes	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Pharyngitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Pneumonia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Respiratory Tract Infection Viral	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Rhinitis	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Upper Respiratory Tract Infection	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Urinary Tract Infection	14.3% 2/14 • Number of events 6 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Viral Parotitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Infections and infestations Viral Pharyngitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Blood and lymphatic system disorders Anaemia	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Blood and lymphatic system disorders Lymphadenopathy	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Blood and lymphatic system disorders Lymphopenia	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Blood and lymphatic system disorders Neutropenia	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Immune system disorders Cytokine Release Syndrome	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Endocrine disorders Glucocorticoid Deficiency	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Endocrine disorders Hypothyroidism	21.4% 3/14 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Endocrine disorders Immune-Mediated Hypothyroidism	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Endocrine disorders Thyroiditis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Metabolism and nutrition disorders Hypocalcaemia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Metabolism and nutrition disorders Hypokalaemia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Metabolism and nutrition disorders Hypomagnesaemia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Nervous system disorders Headache	14.3% 2/14 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Nervous system disorders Neuralgia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Eye disorders Photophobia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Eye disorders Vitreous Floaters	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Vascular disorders Vasculitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Productive Cough	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Abdominal Pain	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Dyspepsia	14.3% 2/14 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Odynophagia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Stomatitis	21.4% 3/14 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Hepatobiliary disorders Hepatitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Hepatobiliary disorders Hyperbilirubinaemia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Hepatobiliary disorders Hypertransaminasaemia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Dermatitis	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Eczema	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Pruritus	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Rash	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Rash Erythematous	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	14.3% 2/14 • Number of events 4 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Skin and subcutaneous tissue disorders Vitiligo	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders Back Pain	14.3% 2/14 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders Joint Stiffness	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Renal and urinary disorders Urinary Incontinence	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
General disorders Asthenia	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
General disorders Pyrexia	21.4% 3/14 • Number of events 3 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
General disorders Swelling Face	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Alanine Aminotransferase Increased	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Aspartate Aminotransferase Increased	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Blood Alkaline Phosphatase Increased	7.1% 1/14 • Number of events 2 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Blood Bilirubin Increased	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Blood Sodium Decreased	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Blood Thyroid Stimulating Hormone Increased	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Investigations Lymphocyte Count Increased	7.1% 1/14 • Number of events 1 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.
Injury, poisoning and procedural complications Infusion Related Reaction	78.6% 11/14 • Number of events 94 • Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 32 months. Analysis was performed on the exposed population.

Additional Information

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