Trial Outcomes & Findings for Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NCT NCT02605967)

NCT ID: NCT02605967

Last Updated: 2022-02-10

Results Overview

PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Number of participants in each category (progression, death, censored) is reported in this record.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 122 participants
• Primary outcome timeframe: From randomization up to maximum 3.3 years
• Results posted on: 2022-02-10

Participant Flow

Participants took part in 19 investigative sites in 7 countries.

The screening period began once patients had signed the study informed consent. All screening evaluations were performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the study treatment. After screening, the treatment period started on Cycle 1 Day 1.

Participant milestones

Measure	Spartalizumab 400 mg Q4W anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice
Overall Study STARTED	82	40
Overall Study Safety Set	82	39
Overall Study Crossover to Spartalizumab	0	27
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	82	40

Reasons for withdrawal

Measure	Spartalizumab 400 mg Q4W anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice
Overall Study subject / guardian decision	1	2
Overall Study Physician Decision	10	1
Overall Study Death	4	2
Overall Study Adverse Event	1	0
Overall Study progressive disease	66	35

Baseline Characteristics

Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Baseline characteristics by cohort

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Total n=122 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 11.54 • n=5 Participants	50.5 years STANDARD_DEVIATION 12.32 • n=7 Participants	50.9 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	33 Participants n=7 Participants	101 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	70 Participants n=5 Participants	37 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to maximum 3.3 years

Population: All participants to whom study treatment was assigned by randomization.

PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Number of participants in each category (progression, death, censored) is reported in this record.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death number of deaths	3 Participants	1 Participants	—
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death number of progression	62 Participants	32 Participants	—
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death number of censored	17 Participants	7 Participants	—

PRIMARY outcome

Timeframe: From randomization up to maximum 3.3 years

Population: All participants to whom study treatment was assigned by randomization.

PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Median PFS	1.9 months Interval 1.8 to 2.9	5.6 months Interval 3.7 to 9.2	—

SECONDARY outcome

Timeframe: From randomization up to maximum 4.8 years.

Population: All participants to whom study treatment was assigned by randomization.

Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient is not known to have died, survival is censored at the date of last known date the patient was alive.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Overall Survival (OS)	20.1 months Interval 13.6 to 25.5	16.0 months Interval 8.8 to 22.5	—

SECONDARY outcome

Timeframe: From randomization up to maximum 3.3 years

Population: All participants to whom study treatment was assigned by randomization.

ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on central review of overall lesion response according to RECIST 1.1.

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Overall Response Rate (ORR) as Per RECIST v 1.1	15 Participants	13 Participants	—

SECONDARY outcome

Timeframe: From randomization up to maximum 3.3 years

Population: All participants for whom best overall response is complete response (CR) or partial response (PR) as per RECIST 1.1 based on central review.

DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR) based on central review of overall lesion response according to RECIST 1.1. DOR is defined as the time between the date of first documented response (confirmed CR or confirmed PR) and the date of first documented disease progression or death due to underlying cancer. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=15 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=13 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Duration of Response (DOR) as Per RECIST v 1.1	10.2 months Interval 7.4 to Not estimable due to insufficient number of participants with events.	5.7 months Interval 3.7 to 7.4	—

SECONDARY outcome

Timeframe: From randomization up to maximum 3.3 years

Population: All participants to whom study treatment was assigned by randomization.

TTP is defined as time from date of randomization to the date of event defined as the first documented progression or death due to underlying cancer. If a subject did not had an event, TTP was censored at the date of last adequate tumor assessment.

Tumor response was based on central review of tumor scan and the assessment criteria was RECIST v1.1. Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Time to Progression (TTP) as Per RECIST v 1.1	1.9 months Interval 1.8 to 2.9	5.6 months Interval 3.7 to 9.3	—

SECONDARY outcome

Timeframe: From randomization up to maximum 3.3 years

Population: All participants to whom study treatment was assigned by randomization to spartalizumab. For the chemotherapy arm, tumor scans for efficacy assessment as per irRC were not planned.

irPFS is the time from the date of randomization to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

Tumor response was based on central review of tumor scan and the assessment criteria was immune-related Response Criteria (irRC). Immune-related progressive disease is at least a 20% increase in the sum of diameters of all measured target lesions including new measurable lesions.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Immune-related Progression-free Survival (irPFS) as Per irRC	1.9 months Interval 1.8 to 3.6	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days.

Population: All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Maximum Observed Serum Concentration (Cmax) of Spartalizumab Cycle 1	116 ug/mL Geometric Coefficient of Variation 21.9	—	—
Maximum Observed Serum Concentration (Cmax) of Spartalizumab Cycle 3	149 ug/mL Geometric Coefficient of Variation 25.8	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days.

Population: All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab Cycle 1	1.57 hours Interval 0.58 to 3.17	—	—
Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab Cycle 3	1.57 hours Interval 1.0 to 14.9	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days.

Population: All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. The duration of the dosing interval (tau) was 28 days.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of Spartalizumab Cycle 1	1340 day*ug/mL Geometric Coefficient of Variation 25.8	—	—
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of Spartalizumab Cycle 3	2260 day*ug/mL Geometric Coefficient of Variation 30.6	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days.

Population: All participants who had at least one dose of spartalizumab and the extrapolation of AUC to infinity could be calculated as described in the description of the endpoint. PK samples were only collected in participants to whom spartalizumab was assigned by randomization.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. The extrapolation of AUC to infinity could be calculated if the percentage of area extrapolated was less than 20% and the regression analysis of the terminal serum elimination phase met a pre-defined criteria of goodness of fit.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=7 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Spartalizumab Cycle 1	1180 day*ug/mL Geometric Coefficient of Variation 23.9	—	—
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Spartalizumab Cycle 3	1090 day*ug/mL Geometric Coefficient of Variation 84.8	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days.

Population: All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Racc was calculated as the ratio between AUCtau Cycle 3 and AUCtau Cycle 1.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=39 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Accumulation Ratio (Racc) of Spartalizumab	1.61 ratio Geometric Coefficient of Variation 19.6	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days.

Population: All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Terminal Elimination Half-life (T1/2) of Spartalizumab Cycle 1	20.1 days Interval 7.35 to 41.5	—	—
Terminal Elimination Half-life (T1/2) of Spartalizumab Cycle 3	22.7 days Interval 5.29 to 48.9	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 655 days).

Population: All participants who had at least one dose of spartalizumab and had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable. IG samples were only collected in participants to whom spartalizumab was assigned by randomization.

Validated immunoassays were used for screening and confirmation of the presence of anti-spartalizumab antibodies (ADA, anti-drug antibodies) in serum. Number of participants with each ADA status is reported in this record.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=72 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Number of Participants With Anti-spartalizumab Antibodies ADA-negative at baseline	66 Participants	—	—
Number of Participants With Anti-spartalizumab Antibodies ADA-positive at baseline	6 Participants	—	—
Number of Participants With Anti-spartalizumab Antibodies ADA-negative at post-baseline	59 Participants	—	—
Number of Participants With Anti-spartalizumab Antibodies ADA-positive at post-baseline (i.e. ADA incidence)	9 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (screening), Cycle 3 Day 1. The duration of one cycle was 28 days.

Population: All participants to whom study treatment was assigned by randomization to spartalizumab and had a valid assessment for the outcome measure. Biomarker samples were not collected in participants randomized to chemotherapy.

The expression of programmed cell death-ligand 1 (PD-L1) was measured in tumor samples by immunohistochemical methods. This record summarizes the PD-L1 positivity percentage in tumor samples.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=79 tumor samples anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
PD-L1 Percent Positive Tumor Baseline	20.00 PD-L1 positivity percentage Interval 0.0 to 100.0	—	—
PD-L1 Percent Positive Tumor Cycle 3 Day 1	90.00 PD-L1 positivity percentage Interval 90.0 to 90.0	—	—

SECONDARY outcome

Timeframe: Baseline (screening), Cycle 3 Day 1. The duration of one cycle was 28 days.

Population: All participants to whom study treatment was assigned by randomization to spartalizumab and had a valid assessment for the outcome measure. Biomarker samples were not collected in participants randomized to chemotherapy.

The expression of CD8 was measured in tumor samples by immunohistochemical methods. This record summarizes the percent marker area for CD8 expression in tumor samples.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=79 tumor samples anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Percent Marker Area for CD8 Expression in Tumor Samples Baseline	4.23 CD8 percent marker area Interval 0.1 to 31.8	—	—
Percent Marker Area for CD8 Expression in Tumor Samples Cycle 3 Day 1	2.22 CD8 percent marker area Interval 2.22 to 2.22	—	—

SECONDARY outcome

Timeframe: Baseline (screening), Cycle 3 Day 1. The duration of one cycle was 28 days.

Population: All participants to whom study treatment was assigned by randomization to spartalizumab and had paired tumor biopsies. Biomarker samples were not collected in participants randomized to chemotherapy.

The count of tumor-infiltrating lymphocytes (TILs) was measured in baseline (screening) and post-baseline paired tumor samples by immunohistochemical methods. This record summarizes the TIL count in tumor samples.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=1 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
TIL Count in Tumor Samples Baseline	10 TILs	—	—
TIL Count in Tumor Samples Cycle 3 Day 1	15 TILs	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Cycle 1 Day 1), Cycle 1 Day 15, Cycle 2 Day 15 and end of treatment (assessed up to maximum 4 years). The duration of one cycle was 28 days.

Population: All participants to whom study treatment was assigned by randomization to spartalizumab. Biomarker samples were not collected in participants randomized to chemotherapy.

The levels of interferon-gamma (IFN-gamma) were measured in plasma samples by immunoassay methods. This record summarizes the fold change from baseline in IFN-gamma levels in plasma.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Fold Change From Baseline in IFN-gamma Levels in Plasma Cycle 1 Day 15	1.53 fold change Interval 0.2 to 14.3	—	—
Fold Change From Baseline in IFN-gamma Levels in Plasma Cycle 2 Day 15	1.31 fold change Interval 0.1 to 35.2	—	—
Fold Change From Baseline in IFN-gamma Levels in Plasma End of treatment	1.11 fold change Interval 0.1 to 3.8	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Cycle 1 Day 1), Cycle 1 Day 15, Cycle 2 Day 15 and end of treatment (assessed up to maximum 4 years). The duration of one cycle was 28 days.

Population: All participants to whom study treatment was assigned by randomization to spartalizumab. Biomarker samples were not collected in participants randomized to chemotherapy.

The levels of interleukin-6 (IL-6) were measured in plasma samples by immunoassay methods. This record summarizes the fold change from baseline in IL-6 levels in plasma.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Fold Change From Baseline in IL-6 Levels in Plasma Cycle 1 Day 15	1.10 fold change Interval 0.2 to 3.3	—	—
Fold Change From Baseline in IL-6 Levels in Plasma Cycle 2 Day 15	1.35 fold change Interval 0.2 to 6.3	—	—
Fold Change From Baseline in IL-6 Levels in Plasma End of treatment	1.41 fold change Interval 0.2 to 7.7	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose on Cycle 1 Day 1), Cycle 1 Day 15, Cycle 2 Day 15 and end of treatment (assessed up to maximum 4 years). The duration of one cycle was 28 days.

Population: All participants to whom study treatment was assigned by randomization to spartalizumab. Biomarker samples were not collected in participants randomized to chemotherapy.

The levels of tumor necrosis factor-alpha (TNF-alfa) were measured in plasma samples by immunoassay methods. This record summarizes the fold change from baseline in TNF-alfa levels in plasma.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Fold Change From Baseline in TNF-alfa Levels in Plasma Cycle 1 Day 15	1.32 fold change Interval 0.4 to 2.2	—	—
Fold Change From Baseline in TNF-alfa Levels in Plasma Cycle 2 Day 15	1.39 fold change Interval 0.3 to 3.1	—	—
Fold Change From Baseline in TNF-alfa Levels in Plasma End of treatment	1.67 fold change Interval 0.3 to 3.7	—	—

POST_HOC outcome

Timeframe: From first dose of spartalizumab up to maximum 0.6 years

Population: All participants who crossed over from chemotherapy to spartalizumab.

PFS is the time from the date of first dose of spartalizumab to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Number of participants in each category (progression, death, censored) is reported in this record.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=27 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment in Participants Who Crossed Over - Number of Participants With Progression or Death number of progression	20 Participants	—	—
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment in Participants Who Crossed Over - Number of Participants With Progression or Death number of deaths	5 Participants	—	—
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment in Participants Who Crossed Over - Number of Participants With Progression or Death number of censored	2 Participants	—	—

POST_HOC outcome

Timeframe: From first dose of spartalizumab up to maximum 0.6 years

Population: All participants who crossed over from chemotherapy to spartalizumab.

PFS is the time from the date of first dose of spartalizumab to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=27 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab Patients treated with chemotherapy who crossed over to spartalizumab
Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment in Participants Who Crossed Over - Median PFS	1.7 months Interval 1.6 to 1.9	—	—

POST_HOC outcome

Timeframe: Up to 4.0 years (on-treatment deaths) and 4.8 years (all deaths).

Population: All participants to whom study treatment was assigned by randomization.

On-treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 4.0 years. Post-treatment deaths were collected after the on-treatment period (starting at day 31 after last dose of study treatment), up to 4.8 years.

For the crossover patients, the deaths collected before crossing over are summarized in the chemotherapy arm and the deaths collected after the crossover are summarized in the crossover arm.

Outcome measures

Measure	Spartalizumab 400 mg Q4W n=82 Participants anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=40 Participants Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab n=27 Participants Patients treated with chemotherapy who crossed over to spartalizumab
All Collected Deaths Total Deaths	48 participants	9 participants	19 participants
All Collected Deaths Deaths on-treatment	5 participants	3 participants	3 participants

Adverse Events

Spartalizumab 400 mg Q4W

Serious events: 28 serious events

Other events: 76 other events

Deaths: 5 deaths

Chemotherapy

Serious events: 15 serious events

Other events: 37 other events

Deaths: 3 deaths

Crossover to Spartalizumab

Serious events: 12 serious events

Other events: 25 other events

Deaths: 3 deaths

All Spartalizumab Participants

Serious events: 40 serious events

Other events: 101 other events

Deaths: 8 deaths

Serious adverse events

Measure	Spartalizumab 400 mg Q4W n=82 participants at risk anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=39 participants at risk Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab n=27 participants at risk Patients treated with chemotherapy who crossed over to spartalizumab	All Spartalizumab Participants n=109 participants at risk All participants who received at least one dose of spartalizumab
Blood and lymphatic system disorders Anaemia	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Febrile neutropenia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	10.3% 4/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Cardiac disorders Angina pectoris	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Cardiac disorders Myocardial infarction	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Cardiac disorders Pericardial effusion	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Eye disorders Papilloedema	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain upper	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Ascites	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Duodenal ulcer	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Dysphagia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Stomatitis	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Vomiting	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Asthenia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Fatigue	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Generalised oedema	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Oedema peripheral	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Pain	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Peripheral swelling	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Pyrexia	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 4/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Hepatobiliary disorders Hepatocellular injury	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Brain abscess	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Conjunctivitis	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Gastroenteritis	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Lower respiratory tract infection	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Pneumonia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Sepsis	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Septic shock	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Sinusitis	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Injury, poisoning and procedural complications Electrical burn	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Aspartate aminotransferase increased	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Bilirubin conjugated increased	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Blood bilirubin increased	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Blood bilirubin unconjugated increased	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hyponatraemia	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Malnutrition	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Diplegia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Hemiparesis	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Spinal cord compression	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Renal and urinary disorders Acute kidney injury	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Renal and urinary disorders Urinary retention	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Angioedema	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Social circumstances Miscarriage of partner	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.

Other adverse events

Measure	Spartalizumab 400 mg Q4W n=82 participants at risk anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab	Chemotherapy n=39 participants at risk Commonly used chemotherapy as per investigator's choice	Crossover to Spartalizumab n=27 participants at risk Patients treated with chemotherapy who crossed over to spartalizumab	All Spartalizumab Participants n=109 participants at risk All participants who received at least one dose of spartalizumab
Gastrointestinal disorders Constipation	15.9% 13/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	17.9% 7/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.7% 16/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Anaemia	23.2% 19/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	48.7% 19/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	22.2% 6/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	22.9% 25/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Leukopenia	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Neutropenia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	30.8% 12/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Endocrine disorders Hypothyroidism	12.2% 10/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.9% 13/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Abdominal distension	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.8% 4/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	8.3% 9/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain upper	9.8% 8/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	10.1% 11/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 5/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Dry mouth	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 4/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Dyspepsia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Dysphagia	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	4.6% 5/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Nausea	15.9% 13/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	20.5% 8/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.8% 4/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.6% 17/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Oral pain	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Stomatitis	7.3% 6/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	23.1% 9/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Gastrointestinal disorders Vomiting	17.1% 14/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	25.9% 7/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	19.3% 21/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Asthenia	13.4% 11/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.0% 12/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Fatigue	17.1% 14/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	38.5% 15/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	18.5% 5/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	17.4% 19/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Malaise	7.3% 6/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	6.4% 7/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Oedema peripheral	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 5/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Peripheral swelling	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Pyrexia	19.5% 16/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	29.6% 8/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	22.0% 24/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
General disorders Swelling face	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Herpes zoster	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Nasopharyngitis	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Pneumonia	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Sinusitis	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Upper respiratory tract infection	11.0% 9/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	9.2% 10/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Infections and infestations Urinary tract infection	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Alanine aminotransferase increased	8.5% 7/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.3% 8/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Aspartate aminotransferase increased	18.3% 15/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	17.9% 7/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.6% 17/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Blood alkaline phosphatase increased	4.9% 4/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Blood creatinine increased	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Blood thyroid stimulating hormone increased	7.3% 6/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Lymphocyte count decreased	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 4/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Neutrophil count decreased	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Platelet count decreased	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	17.9% 7/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations Weight decreased	11.0% 9/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 5/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	8.3% 9/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Investigations White blood cell count decreased	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	20.5% 8/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Decreased appetite	19.5% 16/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	23.1% 9/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	29.6% 8/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	22.0% 24/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Dehydration	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hyperglycaemia	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	4.6% 5/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hypoalbuminaemia	7.3% 6/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	8.3% 9/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hypokalaemia	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	33.3% 13/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.8% 4/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	8.3% 9/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hypomagnesaemia	8.5% 7/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	8.3% 9/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hyponatraemia	17.1% 14/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.8% 4/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	16.5% 18/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	11.0% 9/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	18.5% 5/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 14/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Back pain	11.0% 9/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.8% 4/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.9% 13/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Bone pain	4.9% 4/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	4.6% 5/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Muscular weakness	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.9% 4/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 4/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Myalgia	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Dizziness	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.6% 1/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.3% 8/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Headache	14.6% 12/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	10.3% 4/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.9% 13/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Hypoaesthesia	4.9% 4/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 5/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.5% 6/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Neuropathy peripheral	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 5/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	4.6% 5/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	10.3% 4/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Psychiatric disorders Insomnia	11.0% 9/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.0% 12/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Renal and urinary disorders Urinary retention	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	20.7% 17/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	30.8% 12/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	16.5% 18/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.9% 4/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 4/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.6% 12/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	13.8% 15/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.2% 10/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	9.2% 10/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 3/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 4/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	11.1% 3/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	4.6% 5/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Productive cough	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	1.8% 2/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 2/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	23.1% 9/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Dry skin	6.1% 5/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	6.4% 7/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.92% 1/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Pruritus	12.2% 10/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.7% 3/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.8% 4/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	12.8% 14/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash	18.3% 15/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	15.4% 6/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	3.7% 1/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	14.7% 16/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	0.00% 0/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.
Vascular disorders Hypertension	1.2% 1/82 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	5.1% 2/39 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	7.4% 2/27 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.	2.8% 3/109 • From first dose of study treatment up to 30 days after last dose (maximum 4.0 years). For the crossover patients, safety data collected before crossing over is summarized in the chemotherapy arm and safety data collected after the crossover is summarized in the crossover arm. The column 'all spartalizumab participants' summarizes the safety data of the 2 arms with spartalizumab dosing. AEs and mortality are assessed in the safety set that includes all patients who received at least 1 dose of study medication and had at least 1 valid post-screening/post-baseline safety assessment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER