Trial Outcomes & Findings for A Study of Isatuximab-based Therapy in Participants With Lymphoma (NCT NCT03769181)

NCT ID: NCT03769181

Last Updated: 2025-09-23

Results Overview

DLTs: Adverse Events (AEs) occurring during 1st treatment cycle, unless due to disease progression or obviously unrelated cause which included: hematological abnormalities: Grade(G) 4 neutropenia(N) for 7 or more consecutive days, G3 to G4 N with fever (temperature greater than or equal to \[\>=\] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding requiring clinical intervention or non-hematological abnormalities: G 4 non-hematologic AE, G\>=2 uveitis, G3 non-hematological AE lasting greater than (\>)3 days, delay in initiation of Cycle 2 \>14 days due to treatment related laboratory abnormalities/AE. Any other AE that the study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: Cycle 1 (28 days)
• Results posted on: 2025-09-23

Participant Flow

Study was conducted at 20 sites in 7 countries. A total of 58 participants were enrolled between 11 December 2018 and 27 August 2020 and received isatuximab in combination with cemiplimab. Study was planned to be conducted in 2 parts: Phase 1(safety run-in) and Phase 2 (efficacy/2-stage design).

Efficacy results observed in Cohorts B & C didn't fulfill preplanned interim analysis criteria allowing the study to move to Phase(Ph) 2 Stage 2 in these cohorts. Efficacy results observed in Cohorts A1 & A2 fulfilled preplanned interim analysis criteria in Stage 1 to move to Ph 2 Stage 2 in these cohorts. However, study was stopped for all cohorts per sponsor's decision. Participant flow, Baseline,outcome measures & safety data were prespecified to be analyzed on combined Ph 1 & 2 populations.

Participant milestones

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab Classic Hodgkin's lymphoma (cHL), anti-programmed cell death protein 1/ligand 1 (PD-1/PD-L1) inhibitor naïve participants with received isatuximab 10 mg/kg, IV infusion once a week (QW) in Cycle 1 and then every 2 weeks (Q2W) from Cycle 2 to Cycle 6 (each cycle of 28 days), and then every 3 weeks (Q3W) from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable adverse events (AEs) or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of complete response \[CR\], whichever was longer) of delivery of investigational medicinal product(s) without documented progressive disease (PD), or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab Diffuse large B-cell lymphoma (DLBCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab Peripheral T-cell lymphoma (PTCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Study STARTED	18	12	17	11
Overall Study COMPLETED	5	4	0	0
Overall Study NOT COMPLETED	13	8	17	11

Reasons for withdrawal

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab Classic Hodgkin's lymphoma (cHL), anti-programmed cell death protein 1/ligand 1 (PD-1/PD-L1) inhibitor naïve participants with received isatuximab 10 mg/kg, IV infusion once a week (QW) in Cycle 1 and then every 2 weeks (Q2W) from Cycle 2 to Cycle 6 (each cycle of 28 days), and then every 3 weeks (Q3W) from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable adverse events (AEs) or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of complete response \[CR\], whichever was longer) of delivery of investigational medicinal product(s) without documented progressive disease (PD), or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab Diffuse large B-cell lymphoma (DLBCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab Peripheral T-cell lymphoma (PTCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Overall Study Other - Unspecified	2	1	0	0
Overall Study Adverse Event	1	0	2	4
Overall Study Withdrawal by Subject	1	0	2	1
Overall Study Progressive disease	9	7	13	6

Baseline Characteristics

A Study of Isatuximab-based Therapy in Participants With Lymphoma

Baseline characteristics by cohort

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Total n=58 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 20.1 • n=93 Participants	38.0 years STANDARD_DEVIATION 15.5 • n=4 Participants	60.8 years STANDARD_DEVIATION 14.2 • n=27 Participants	65.5 years STANDARD_DEVIATION 8.8 • n=483 Participants	52.0 years STANDARD_DEVIATION 18.8 • n=36 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	4 Participants n=483 Participants	22 Participants n=36 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants	7 Participants n=483 Participants	36 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	8 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants	7 Participants n=483 Participants	31 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	7 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	19 Participants n=36 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Population: Analysis was performed on DLT evaluable population which included all participants who received the planned doses of isatuximab and cemiplimab during Cycle 1 and completed the DLT observation period after the first administration of the study drug. Here, "0" in the "overall number of participants analyzed" signifies that no participants were evaluable for DLTs in the Cohort A1 arm.

DLTs: Adverse Events (AEs) occurring during 1st treatment cycle, unless due to disease progression or obviously unrelated cause which included: hematological abnormalities: Grade(G) 4 neutropenia(N) for 7 or more consecutive days, G3 to G4 N with fever (temperature greater than or equal to [>=] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding requiring clinical intervention or non-hematological abnormalities: G 4 non-hematologic AE, G>=2 uveitis, G3 non-hematological AE lasting greater than (>)3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. Any other AE that the study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=1 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=3 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=1 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Dose Limiting Toxicities (DLTs)	—	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population which included all participants who signed the informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab.

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence 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, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study treatment up to 30 days after the last dose of study treatment).

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	16 Participants	12 Participants	17 Participants	11 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	3 Participants	2 Participants	10 Participants	7 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population.

Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Abnormality criteria was assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Laboratory Abnormalities: Hematological Parameters Anemia: Grade 1	9 Participants	6 Participants	7 Participants	6 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Anemia: Grade 2	5 Participants	1 Participants	7 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Anemia: Grade 3	2 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Anemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters White blood cell decreased: Grade 1	10 Participants	2 Participants	9 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters White blood cell decreased: Grade 2	1 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters White blood cell decreased: Grade 3	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters White blood cell decreased: Grade 4	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Platelet count decreased: Grade 1	8 Participants	3 Participants	7 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Platelet count decreased: Grade 2	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Platelet count decreased: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Platelet count decreased: Grade 4	0 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Lymphocyte count decreased: Grade 1	4 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Lymphocyte count decreased: Grade 2	3 Participants	0 Participants	4 Participants	6 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Lymphocyte count decreased: Grade 3	5 Participants	1 Participants	6 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Lymphocyte count decreased: Grade 4	1 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Neutrophil count decreased: Grade 1	0 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Neutrophil count decreased: Grade 2	3 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Neutrophil count decreased: Grade 3	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Hematological Parameters Neutrophil count decreased: Grade 4	0 Participants	0 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population. Here "number analyzed" signifies the participants with available data for each specified parameter.

Electrolyte parameters assessed were hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Abnormal criteria was assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Laboratory Abnormalities: Electrolytes Hypercalcemia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyponatremia: Grade 1	8 Participants	4 Participants	6 Participants	5 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyponatremia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyponatremia: Grade 3	0 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyponatremia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypokalemia: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypokalemia: Grade 2	3 Participants	3 Participants	3 Participants	5 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypokalemia: Grade 3	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypokalemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperkalemia: Grade 1	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperkalemia: Grade 2	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperkalemia: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperkalemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypocalcemia: Grade 1	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypocalcemia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypocalcemia: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypocalcemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoalbuminemia: Grade 1	3 Participants	2 Participants	5 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoalbuminemia: Grade 2	4 Participants	0 Participants	6 Participants	5 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoalbuminemia: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoalbuminemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoglycemia: Grade 1	5 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoglycemia: Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoglycemia: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypoglycemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperglycemia: Grade 1	2 Participants	5 Participants	1 Participants	6 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperglycemia: Grade 2	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperglycemia: Grade 3	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hyperglycemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypercalcemia: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypercalcemia: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Electrolytes Hypercalcemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population.

Abnormal renal parameters assessed were glomerular filtration rate (GFR) by class, creatinine increased and hyperuricemia. GFR by class was assessed in categories:>=90 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) (Normal), >=60 to <90 mL/min/1.73m^2 (Mild), >=30 to <60 mL/min/1.73m^2 (Moderate), >=15 to <30 mL/min/1.73m^2 (Severe), and <15 mL/min/1.73m^2 (End Stage Renal Disease). Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Laboratory Abnormalities: Renal Parameters Hyperuricemia: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters GFR: >=90 mL/min/1.73m^2	7 Participants	2 Participants	4 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters GFR: >=60 to <90 mL/min/1.73m^2	8 Participants	8 Participants	8 Participants	7 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters GFR: >=30 to <60 mL/min/1.73m^2	3 Participants	2 Participants	4 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters GFR: >=15 to <30 mL/min/1.73m^2	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters GFR: <15 mL/min/1.73m^2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Creatinine increased: Grade 1	2 Participants	3 Participants	4 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Creatinine increased: Grade 2	3 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Creatinine increased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Creatinine increased: Garde 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Hyperuricemia: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Hyperuricemia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Renal Parameters Hyperuricemia: Grade 3	1 Participants	3 Participants	5 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population.

Abnormal liver function parameters assessed were aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Laboratory Abnormalities: Liver Function Parameters AST increased: Grade 1	3 Participants	2 Participants	5 Participants	3 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters AST increased: Grade 2	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters AST increased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters AST increased: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALT increased: Grade 1	1 Participants	7 Participants	6 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALT increased: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALT increased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALT increased: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALP increased: Grade 1	3 Participants	5 Participants	4 Participants	5 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALP increased: Grade 2	2 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALP increased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters ALP increased: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters BB increased: Grade 1	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters BB increased: Grade 2	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters BB increased: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities: Liver Function Parameters BB increased: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the date of randomization until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified in protocol.

Percentage of participants who had a CR as a best overall response (BOR) using the Lugano response criteria (LRC) 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT response was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Cohort A1: Percentage of Participants With Complete Response (CR)	27.8 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population.

Percentage of participants who had a CR or partial response (PR) as BOR using LRC, 2014. Per LRC, CR (PET-CT): complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (PET-CT): partial MR in lymph nodes and extralymphatic sites; no new lesions and residual uptake higher than uptake. PR (Per CT): lymph nodes, extralymphatic sites>=50% decrease in sum of product of perpendicular diameters (SPD), extranodal sites; if lesion is too small to measure on CT,assign5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=11 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Cohort A2, B and C: Percentage of Participants With Objective Response (OR)	33.3 percentage of participants Interval 12.3 to 60.9	5.9 percentage of participants Interval 0.3 to 25.0	9.1 percentage of participants Interval 0.5 to 36.4	—

SECONDARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on Anti-drug antibody (ADA) evaluable population that included all participants who signed informed consent and received at least 1 dose of either isatuximab or cemiplimab, with at least 1 non-missing ADA result after the drug administration. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=6 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=5 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab Treatment-Induced ADA	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab Treatment-Boosted ADA	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks)

Population: Analysis was performed on ADA evaluable population. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=11 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=10 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=6 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab Treatment-Induced ADA	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab Treatment-Boosted ADA	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of infusion (EOI up to 3 hours) on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab) which included participants who signed informed consent and received at least 1 dose of the drug with at least one reportable concentration after the study drug (isatuximab) administration. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)	221 micrograms per milliliter (mcg/mL) Standard Deviation 47.2	263 micrograms per milliliter (mcg/mL) Standard Deviation 39.4	235 micrograms per milliliter (mcg/mL) Standard Deviation 39.3	181 micrograms per milliliter (mcg/mL) Standard Deviation 35.7

SECONDARY outcome

Timeframe: At Start of infusion (SOI; 0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Cmax was defined as the maximum plasma concentration observed after the first administration of drug.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Maximum Observed Plasma Concentration (Cmax) After the First Infusion of Isatuximab	226 mcg/mL Standard Deviation 48.1	265 mcg/mL Standard Deviation 38.8	253 mcg/mL Standard Deviation 29.1	181 mcg/mL Standard Deviation 35.7

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Tmax was defined as the time to reach Cmax, after the intravenous infusion of isatuximab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Isatuximab	5.95 hours Interval 2.0 to 8.92	5.23 hours Interval 3.0 to 8.83	5.26 hours Interval 2.6 to 10.5	4.57 hours Interval 2.33 to 7.45

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration, calculated for isatuximab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Area Under the Plasma Concentration (AUClast) Versus Time Curve After the First Infusion of Isatuximab	20400 hours*mcg/mL Standard Deviation 5190	22700 hours*mcg/mL Standard Deviation 6020	21700 hours*mcg/mL Standard Deviation 4610	14400 hours*mcg/mL Standard Deviation 4710

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab	93.3 mcg/mL Standard Deviation 28.1	110 mcg/mL Standard Deviation 24.5	89.8 mcg/mL Standard Deviation 24.7	40.4 mcg/mL Standard Deviation 17.7

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Tlast was defined as the time of last concentration observed above the lower limit of quantification for isatuximab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Time of Clast (Tlast) After the First Infusion of Isatuximab	142 hours Interval 136.0 to 174.0	143 hours Interval 72.6 to 167.0	143 hours Interval 137.0 to 147.0	144 hours Interval 142.0 to 169.0

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated for isatuximab. Samples for this outcome measure were collected up to 144 hours post-dose. No sample was collected at 168 hours post-dose; and thus, the samples collected up to 144 hours post-dose were extrapolated to derive data for 168 hours post-dose.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=11 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-168 Hours) After the First Infusion of Isatuximab	22500 hour*mcg/mL Standard Deviation 5770	26600 hour*mcg/mL Standard Deviation 4030	23700 hour*mcg/mL Standard Deviation 4960	15000 hour*mcg/mL Standard Deviation 4680

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1

Population: Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

AUC0-144 hours was defined as the area under the plasma concentration versus time curve from time 0 to 144 hours post dose calculated for isatuximab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=11 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=14 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=7 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-144 Hours) After the First Infusion of Isatuximab	20400 hours*mcg/mL Standard Deviation 5170	24300 hours*mcg/mL Standard Deviation 3470	21800 hours*mcg/mL Standard Deviation 4550	14000 hours*mcg/mL Standard Deviation 4240

SECONDARY outcome

Timeframe: Pre-infusion on Cycle1:Day 2, 8, 15, & 22, Cycle 2:Day 1 &15, Cycle 3:Day 1 &15, Cycle 4:Day 1 &15, Cycle 5 Day1,Cycle 6 Day1,Cycle 7 Day 1, Cycle 8 Day1, Cycle 9 Day1, Cycle 10 Day1, Cycle 11 Day1, Cycle14 Day1, Cycle 17 Day1, Cycle 20 Day1,Cycle 23 Day1

Population: Analysis was performed on PK population (for isatuximab). Here, '0' in the number analyzed field signifies that none of the participants were available for the specified timepoints.

Ctrough was the plasma concentration of isatuximab observed just before treatment administration during repeated dosing.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=16 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=9 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 1 Day 2	0 mcg/mL Standard Deviation 0	0 mcg/mL Standard Deviation 0	0 mcg/mL Standard Deviation 0	0 mcg/mL Standard Deviation 0
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 1 Day 8	93.1 mcg/mL Standard Deviation 28.1	98.4 mcg/mL Standard Deviation 39.5	93.2 mcg/mL Standard Deviation 27.2	37.7 mcg/mL Standard Deviation 18.0
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 1 Day 15	159 mcg/mL Standard Deviation 47.7	191 mcg/mL Standard Deviation 41.4	181 mcg/mL Standard Deviation 43.7	115 mcg/mL Standard Deviation 89.4
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 1 Day 22	254 mcg/mL Standard Deviation 59.8	262 mcg/mL Standard Deviation 45.2	259 mcg/mL Standard Deviation 57.9	124 mcg/mL Standard Deviation 22.9
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 2 Day 1	310 mcg/mL Standard Deviation 78.2	352 mcg/mL Standard Deviation 48.7	316 mcg/mL Standard Deviation 110	132 mcg/mL Standard Deviation 64.0
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 2 Day 15	314 mcg/mL Standard Deviation 141	390 mcg/mL Standard Deviation 256	291 mcg/mL Standard Deviation 108	129 mcg/mL Standard Deviation 59.1
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 3 Day 1	304 mcg/mL Standard Deviation 79.8	320 mcg/mL Standard Deviation 49.7	327 mcg/mL Standard Deviation 92.4	122 mcg/mL Standard Deviation 58.0
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 3 Day 15	325 mcg/mL Standard Deviation 85.1	336 mcg/mL Standard Deviation 42.3	420 mcg/mL Standard Deviation 67.8	176 mcg/mL Standard Deviation 8.19
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 4 Day 1	334 mcg/mL Standard Deviation 91.8	344 mcg/mL Standard Deviation 58.2	350 mcg/mL Standard Deviation 80.6	149 mcg/mL Standard Deviation 33.2
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 4 Day 15	363 mcg/mL Standard Deviation 122	376 mcg/mL Standard Deviation 65.2	336 mcg/mL Standard Deviation 117	158 mcg/mL Standard Deviation 16.9
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 5 Day 1	385 mcg/mL Standard Deviation 79.9	383 mcg/mL Standard Deviation 71.0	362 mcg/mL	157 mcg/mL Standard Deviation 11.5
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 6 Day 1	379 mcg/mL Standard Deviation 105	361 mcg/mL Standard Deviation 97.8	415 mcg/mL	137 mcg/mL
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 7 Day 1	408 mcg/mL Standard Deviation 141	374 mcg/mL Standard Deviation 107	—	186 mcg/mL
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 8 Day 1	352 mcg/mL Standard Deviation 94.9	356 mcg/mL Standard Deviation 57.7	360 mcg/mL	—
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 9 Day 1	328 mcg/mL Standard Deviation 124	351 mcg/mL Standard Deviation 54.8	—	83.5 mcg/mL
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 10 Day 1	317 mcg/mL Standard Deviation 120	347 mcg/mL Standard Deviation 51.8	383 mcg/mL	—
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 11 Day 1	318 mcg/mL Standard Deviation 147	357 mcg/mL Standard Deviation 52.0	—	—
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 14 Day 1	357 mcg/mL Standard Deviation 119	333 mcg/mL Standard Deviation 28.0	—	—
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 17 Day 1	—	299 mcg/mL Standard Deviation 22.3	—	—
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 20 Day 1	117 mcg/mL	328 mcg/mL Standard Deviation 14.4	—	—
PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab Cycle 23 Day 1	—	309 mcg/mL Standard Deviation 9.90	—	—

SECONDARY outcome

Timeframe: EOI (up to 30 minutes [min]) on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab) which included all participants who signed informed consent and received at least 1 dose of the drug with at least one reportable concentration after the study drug (cemiplimab) administration. Here 'overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Ceoi is the plasma concentration observed at the end of intravenous infusion of cemiplimab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Serum Concentration of Cemiplimab at End of Infusion (CEOI)	63.7 milligrams per milliliter (mg/mL) Standard Deviation 24.2	78.8 milligrams per milliliter (mg/mL) Standard Deviation 24.9	68.1 milligrams per milliliter (mg/mL) Standard Deviation 26.3	66.2 milligrams per milliliter (mg/mL) Standard Deviation 18.4

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Cmax was defined as the maximum concentration observed after the first administration.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Maximum Observed Concentration (Cmax) After the First Infusion of Cemiplimab	70.9 mg/L Standard Deviation 21.1	90.8 mg/L Standard Deviation 19.4	79.0 mg/L Standard Deviation 16.7	77.1 mg/L Standard Deviation 20.7

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Tmax was defined as the time to reach Cmax after the intravenous infusion of cemiplimab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Cemiplimab	4.00 hours Interval 0.48 to 4.67	4.50 hours Interval 0.48 to 4.53	4.05 hours Interval 0.42 to 5.4	2.34 hours Interval 0.5 to 4.08

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

AUClast was defined as area under the serum concentration versus time curve calculated from time 0 to last quantifiable concentration calculated for cemiplimab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Area Under the Serum Concentration (AUClast) Versus Time Curve After the First Infusion of Cemiplimab	524 day*mg/mL Standard Deviation 188	648 day*mg/mL Standard Deviation 112	506 day*mg/mL Standard Deviation 159	466 day*mg/mL Standard Deviation 147

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Clast was defined as the last concentration of cemiplimab observed above the lower limit of quantification.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Cemiplimab	23.4 mg/L Standard Deviation 11.2	30.3 mg/L Standard Deviation 7.16	27.0 mg/L Standard Deviation 9.79	14.3 mg/L Standard Deviation 6.64

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants analyzed" signifies the participants with available data for this outcome measure.

Tlast was defined as the time of last concentration observed above the lower limit of quantification for cemiplimab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Time of Clast (Tlast) After the First Infusion of Cemiplimab	334 hours Interval 164.0 to 672.0	333 hours Interval 330.0 to 362.0	332 hours Interval 164.0 to 339.0	335 hours Interval 171.0 to 572.0

SECONDARY outcome

Timeframe: At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1

Population: Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

AUC0-336 hours was defined as the area under the serum concentration versus time curve from time 0 to 336 hours post dose for cemiplimab.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=17 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=5 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=15 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=8 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUC0-336 Hours) After the First Infusion of Cemiplimab	519 day*mg/mL Standard Deviation 177	645 day*mg/mL Standard Deviation 113	546 day*mg/mL Standard Deviation 136	466 day*mg/mL Standard Deviation 130

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 1:Day 1 & Day15,Cycle 2:Day 1 & Day 15,Cycle 3:Day 1 & Day 15,Cycle 4:Day 1 & Day15,Cycle 5 Day 1,Cycle 6 Day 1,Cycle7 Day1,Cycle 8 Day 1,Cycle 9 Day1,Cycle 10 Day1,Cycle11 Day1,Cycle14 Day 1,Cycle 17 Day1,Cycle20 Day 1,Cycle 23 Day1

Population: Analysis was performed on PK population (for Cemiplimab). Here, '0' in the number analyzed field signifies that none of the participants were available for the specified timepoint.

Ctrough was the serum concentration of cemiplimab observed just before treatment administration during repeated dosing.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 1 Day 1	0.00800 mg/mL Standard Deviation 0.0330	0.980 mg/mL Standard Deviation 2.19	0 mg/mL Standard Deviation 0	0 mg/mL Standard Deviation 0
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 1 Day 15	25.3 mg/mL Standard Deviation 10.2	30.3 mg/mL Standard Deviation 7.16	24.2 mg/mL Standard Deviation 9.91	16.5 mg/mL Standard Deviation 4.83
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 2 Day 1	44.1 mg/mL Standard Deviation 11.2	51.1 mg/mL Standard Deviation 15.8	49.6 mg/mL Standard Deviation 16.3	33.0 mg/mL Standard Deviation 10.4
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 2 Day 15	64.4 mg/mL Standard Deviation 22.5	61.0 mg/mL Standard Deviation 10.8	48.9 mg/mL Standard Deviation 9.16	38.3 mg/mL Standard Deviation 21.1
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 3 Day 1	77.7 mg/mL Standard Deviation 30.2	73.7 mg/mL Standard Deviation 11.0	62.8 mg/mL Standard Deviation 13.6	66.7 mg/mL Standard Deviation 64.7
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 3 Day 15	95.1 mg/mL Standard Deviation 35.0	86.6 mg/mL Standard Deviation 19.5	72.3 mg/mL Standard Deviation 3.80	72.1 mg/mL Standard Deviation 12.1
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 4 Day 1	100 mg/mL Standard Deviation 38.9	84.4 mg/mL Standard Deviation 20.3	76.8 mg/mL Standard Deviation 4.31	66.7 mg/mL Standard Deviation 24.1
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 4 Day 15	113 mg/mL Standard Deviation 44.8	88.2 mg/mL Standard Deviation 30.5	91.6 mg/mL Standard Deviation 10.3	63.5 mg/mL Standard Deviation 24.8
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 5 Day 1	106 mg/mL Standard Deviation 28.9	92.7 mg/mL Standard Deviation 21.8	91.6 mg/mL	73.4 mg/mL Standard Deviation 26.5
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 6 Day 1	114 mg/mL Standard Deviation 37.3	94.8 mg/mL Standard Deviation 29.8	113 mg/mL	73.8 mg/mL
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 7 Day 1	112 mg/mL Standard Deviation 32.6	115 mg/mL Standard Deviation 43.0	—	100 mg/mL
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 8 Day 1	110 mg/mL Standard Deviation 40.5	129 mg/mL Standard Deviation 19.5	93.0 mg/mL	—
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 9 Day 1	107 mg/mL Standard Deviation 36.2	122 mg/mL Standard Deviation 27.9	122 mg/mL	61.8 mg/mL
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 10 Day 1	112 mg/mL Standard Deviation 65.8	139 mg/mL Standard Deviation 23.2	122 mg/mL	—
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 11 Day 1	120 mg/mL Standard Deviation 60.2	133 mg/mL Standard Deviation 14.5	—	—
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 14 Day 1	138 mg/mL Standard Deviation 72.7	127 mg/mL Standard Deviation 17.1	—	—
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 17 Day 1	60.6 mg/mL	131 mg/mL Standard Deviation 18.8	—	—
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 20 Day 1	62.6 mg/mL	137 mg/mL Standard Deviation 26.7	—	—
PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab Cycle 23 Day 1	—	137 mg/mL	—	—

SECONDARY outcome

Timeframe: Up to 103 weeks

Population: Analysis was performed on all treated population. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Tumor burden change was defined as the best percent-change from baseline in a sum of product of lesion diameters (longest for non-nodal lesion, short axis for nodal lesions) for all target lesions.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=10 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=8 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=6 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Percent Change From Baseline in Tumor Burden	-48.8 percent change Standard Deviation 59.0	-55.3 percent change Standard Deviation 32.6	396.0 percent change Standard Deviation 880.7	-9.7 percent change Standard Deviation 87.8

SECONDARY outcome

Timeframe: From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks)

Population: Analysis was performed on participants who had a response. DOR was analyzed using Kaplan-Meier method. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure.

Time (months) between date of first response to first date that recurrent or radiologically disease progression (PD) was documented, or date of death,whichever was 1st. In absence of PD or death before cut-off date or date of initiation of further anticancer treatment, DOR was censored at date of last valid response not showing PD performed prior to initiation of further anticancer treatment or cut-off date, whichever was earlier. PD(PET-CT): metabolic disease with score 4/5 with inc. in intensity of uptake for target nodes/nodal mass & new FDG-avid foci consistent with lymphoma. PD(CT):any 1 of following: cross product of longest transverse diameter of lesion(LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi(SDi) from nadir 0.5 cm, regrowth of resolved lesions, new splenomegaly,progression of non-measured lesion, new/recurrent involvement of bone marrow.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=10 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=4 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=1 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=1 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Duration of Response (DOR)	5.8 months Standard Deviation 5.2	7.3 months Standard Deviation 4.8	17.1 months	14.0 months

SECONDARY outcome

Timeframe: From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population.

DC defined as percentage of participants who achieved CR, PR or stable disease (SD) as per LRC, 2014. CR (PET-CT): complete MR in lymph nodes and extralymphatic sites; no new lesions and no evidence of FDG-avid disease. CR (CT): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow. PR (PET-CT): partial MR in lymph nodes and sites; no new lesions. PR (CT): lymph nodes, sites>=50% decrease in SPD, sites; if lesion is too small to measure on CT, assign 5mm*5mm; No longer visible:0*0mm; Node>5mm*5mm, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. SD (PET-CT):no metabolic response, target nodes score of 4/5 with no significant change & no new lesions; SD (CT): <50% dec in SPD, no increase in progression for. 5PS:1: non-measured lesions, organ enlargement & no new lesions.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Percentage of Participants With Disease Control (DC)	61.1 percentage of participants Interval 39.2 to 80.1	58.3 percentage of participants Interval 31.5 to 81.9	5.9 percentage of participants Interval 0.3 to 25.0	18.2 percentage of participants Interval 3.3 to 47.0

SECONDARY outcome

Timeframe: From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population. PFS was analyzed using Kaplan-Meier method.

PFS: time (in months) from 1st study treatment administration to date of 1st documented radiographic progression or date of death from any cause, whichever occurs 1st. Per LRC, 2014 PD (per PET-CT): metabolic disease with score 4/5 with increase (inc) in intensity of uptake for individual target nodes/nodal mass & new FDG-avid foci consistent with lymphoma at interim/ end-of-treatment assessment for extra nodal lesions, new FDG-avid foci consistent with lymphoma rather; new/recurrent FDG-avid foci bone marrow. PD (per CT response): any 1 of following: cross product of longest transverse diameter of lesion (LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi from nadir 0.5 cm for lesion <= 2 cm, regrowth of resolved lesions, new splenomegaly,progression of preexisting non measured lesion, new/recurrent involvement of bone marrow.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 Participants DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 Participants PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Progression Free Survival (PFS)	5.09 months Interval 2.694 to 13.207	6.21 months Interval 2.595 to 10.349	2.37 months Interval 0.46 to 2.694	2.66 months Interval 0.427 to 6.341

SECONDARY outcome

Timeframe: From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population. Data for cohort B and C are reported separately.

Percentage of participants who had a CR or PR as BOR using LRC, 2014 (based on PET-CT and CT responses). CR (per PET-CT): complete MR in lymph nodes and extra lymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (per PET-CT): partial MR in lymph nodes and extral ymphatic sites; no new lesions and residual uptake higher than uptake. PR (per CT): lymph nodes, extralymphatic sites >=50% decrease in SPD, extranodal sites; if lesion is too small to measure on CT, assign 5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, used actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Cohort A1 and A2: Percentage of Participants With Objective Response	55.6 percentage of participants Interval 34.1 to 75.6	33.3 percentage of participants Interval 12.3 to 60.9	—	—

SECONDARY outcome

Timeframe: From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks)

Population: Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified.

Percentage of participants who had a CR as a BOR using the LRC, 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative.

Outcome measures

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 Participants cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 Participants cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Cohort A1 and A2: Percentage of Participants With Complete Response	27.8 percentage of participants	16.7 percentage of participants	—	—

Adverse Events

Cohort A1: cHL: Isatuximab + Cemiplimab

Serious events: 3 serious events

Other events: 16 other events

Deaths: 4 deaths

Cohort A2: cHL: Isatuximab + Cemiplimab

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Cohort B: DLBCL: Isatuximab + Cemiplimab

Serious events: 10 serious events

Other events: 17 other events

Deaths: 12 deaths

Cohort C: PTCL: Isatuximab + Cemiplimab

Serious events: 7 serious events

Other events: 10 other events

Deaths: 6 deaths

Serious adverse events

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 participants at risk cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 participants at risk cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 participants at risk DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 participants at risk PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Infections and infestations Epstein-Barr Virus Infection	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Herpes Zoster Disseminated	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Meningitis Aseptic	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Pneumonia Bacterial	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Pneumonia Haemophilus	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Pneumonia Respiratory Syncytial Viral	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Streptococcal Sepsis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Urinary Tract Infection	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Urinary Tract Infection Bacterial	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Peripheral Sensorimotor Neuropathy	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Eye disorders Visual Acuity Reduced	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Vascular disorders Subclavian Vein Thrombosis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Abdominal Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Haematemesis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Large Intestinal Obstruction	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Death	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Disease Progression	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Multiple Organ Dysfunction Syndrome	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Performance Status Decreased	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Pyrexia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Investigations Platelet Count Decreased	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.

Other adverse events

Measure	Cohort A1: cHL: Isatuximab + Cemiplimab n=18 participants at risk cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort A2: cHL: Isatuximab + Cemiplimab n=12 participants at risk cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort B: DLBCL: Isatuximab + Cemiplimab n=17 participants at risk DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).	Cohort C: PTCL: Isatuximab + Cemiplimab n=11 participants at risk PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
Infections and infestations Bacteraemia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Bacterial Diarrhoea	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Bronchitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Covid-19	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Cellulitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Cystitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Device Related Infection	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Erysipelas	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Fungal Skin Infection	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Genital Herpes	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Herpes Simplex	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Herpes Zoster	5.6% 1/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Influenza	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Lower Respiratory Tract Infection	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Nasopharyngitis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Oral Candidiasis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Oral Herpes	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Pharyngitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Pneumonia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Pneumonia Staphylococcal	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Postoperative Wound Infection	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Respiratory Tract Infection	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Rhinitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	16.7% 2/12 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Stenotrophomonas Infection	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Tinea Cruris	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Tonsillitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Tooth Infection	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Tracheobronchitis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Trichophytosis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	25.0% 3/12 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Urinary Tract Infection	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Vascular Device Infection	5.6% 1/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Viral Infection	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Infections and infestations Viral Pharyngitis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Associated Fever	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Immune system disorders Hypogammaglobulinaemia	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Metabolism and nutrition disorders Decreased Appetite	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Psychiatric disorders Depression	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Psychiatric disorders Insomnia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	18.2% 2/11 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Psychiatric disorders Nervousness	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Dizziness	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Headache	11.1% 2/18 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Hypoaesthesia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Memory Impairment	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Paraesthesia	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Radiculopathy	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Sciatica	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Sedation	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Nervous system disorders Tremor	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Eye disorders Conjunctival Oedema	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Eye disorders Vision Blurred	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Ear and labyrinth disorders Deafness	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Ear and labyrinth disorders Ear Pruritus	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Ear and labyrinth disorders Hypoacusis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Cardiac disorders Atrial Fibrillation	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Cardiac disorders Extrasystoles	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Cardiac disorders Sinus Tachycardia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Cardiac disorders Tachycardia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Vascular disorders Hypertension	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Vascular disorders Hypotension	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Vascular disorders Lymphorrhoea	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Vascular disorders Phlebitis	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Vascular disorders Varicophlebitis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Nasal Discharge Discolouration	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.6% 1/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Abdominal Distension	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Abdominal Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	23.5% 4/17 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Abdominal Pain Upper	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Ascites	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Constipation	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Diarrhoea	22.2% 4/18 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	33.3% 4/12 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	23.5% 4/17 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	18.2% 2/11 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Dysphagia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	16.7% 2/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Melaena	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	50.0% 6/12 • Number of events 6 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	23.5% 4/17 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Oral Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Gastrointestinal disorders Vomiting	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Hepatobiliary disorders Granulomatous Liver Disease	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Butterfly Rash	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Erythema	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Milia	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Night Sweats	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Pruritus	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	25.0% 3/12 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Rash	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Rash Macular	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Rash Papular	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Back Pain	22.2% 4/18 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Muscle Tightness	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 2/18 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Neck Pain	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Renal and urinary disorders Dysuria	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Renal and urinary disorders Haematuria	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Renal and urinary disorders Pollakiuria	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Reproductive system and breast disorders Haematospermia	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Congenital, familial and genetic disorders Hypertrophic Cardiomyopathy	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Administration Site Extravasation	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Asthenia	16.7% 3/18 • Number of events 4 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Chills	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	11.8% 2/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Fatigue	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	23.5% 4/17 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	18.2% 2/11 • Number of events 2 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Generalised Oedema	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Malaise	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Non-Cardiac Chest Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Oedema Peripheral	16.7% 3/18 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	29.4% 5/17 • Number of events 5 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Pain	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Pyrexia	22.2% 4/18 • Number of events 7 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	25.0% 3/12 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	17.6% 3/17 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	27.3% 3/11 • Number of events 3 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
General disorders Swelling Face	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	5.9% 1/17 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Investigations Gamma-Glutamyltransferase Increased	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Investigations Platelet Count Decreased	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Investigations Weight Decreased	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Investigations Weight Increased	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Eye Injury	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Fall	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Infusion Related Reaction	38.9% 7/18 • Number of events 11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	75.0% 9/12 • Number of events 17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	47.1% 8/17 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	63.6% 7/11 • Number of events 8 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.00% 0/18 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	8.3% 1/12 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Tibia Fracture	5.6% 1/18 • Number of events 1 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/12 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/17 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.	0.00% 0/11 • From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks) Analysis was performed on all-treated population.

Additional Information

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