Trial Outcomes & Findings for A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer (NCT NCT03941873)

NCT ID: NCT03941873

Last Updated: 2024-10-26

Results Overview

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 111 participants
• Primary outcome timeframe: Up to approximately 4 years and 1 month
• Results posted on: 2024-10-26

Participant Flow

This study was conducted at multiple sites in China.

Participant milestones

Measure	Sitravatinib Monotherapy: 80 mg Sitravatinib 80 milligrams (mg) orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) or gastric/gastroesophageal junction (G/GEJ) cancer	Sitravatinib Monotherapy: 120 mg Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Overall Study STARTED	3	24	3	81
Overall Study COMPLETED	1	3	1	8
Overall Study NOT COMPLETED	2	21	2	73

Reasons for withdrawal

Measure	Sitravatinib Monotherapy: 80 mg Sitravatinib 80 milligrams (mg) orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) or gastric/gastroesophageal junction (G/GEJ) cancer	Sitravatinib Monotherapy: 120 mg Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Overall Study Death	0	12	2	53
Overall Study Withdrawal by Subject	1	1	0	5
Overall Study Lost to Follow-up	1	2	0	0
Overall Study Sponsor Decision	0	6	0	15

Baseline Characteristics

A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=24 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=81 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Total n=111 Participants Total of all reporting groups
Age, Continuous	57.7 Years STANDARD_DEVIATION 10.02 • n=5 Participants	53.3 Years STANDARD_DEVIATION 9.92 • n=7 Participants	56.3 Years STANDARD_DEVIATION 6.51 • n=5 Participants	56.4 Years STANDARD_DEVIATION 10.23 • n=4 Participants	55.7 Years STANDARD_DEVIATION 10.1 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	22 Participants n=7 Participants	2 Participants n=5 Participants	71 Participants n=4 Participants	97 Participants n=21 Participants
Race/Ethnicity, Customized Asian: Chinese	3 Participants n=5 Participants	24 Participants n=7 Participants	3 Participants n=5 Participants	81 Participants n=4 Participants	111 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to approximately 4 years and 1 month

Population: The Safety Analysis Set includes all participants who received ≥ 1 dose of any study drug

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=24 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=81 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Number of Participants With Adverse Events At least one TEAE	3 Participants	24 Participants	3 Participants	78 Participants
Number of Participants With Adverse Events At least one SAE	1 Participants	7 Participants	2 Participants	31 Participants

PRIMARY outcome

Timeframe: Up to approximately 4 years and 1 month

Population: The Efficacy Evaluable Analysis Set includes all participants who received ≥ 1 dose of any study drug with measurable disease at baseline per RECIST v1.1 and who had ≥ 1 evaluable postbaseline tumor assessment unless treatment was discontinued due to clinical progression or early death (within 13 weeks after the first dose date) before tumor assessment

ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=20 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=78 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Objective Response Rate (ORR) Anti-PD-1/PD-L1 naïve or R/R HCC	25.0 Percentage of participants Interval 8.7 to 49.1	—	—	—
Objective Response Rate (ORR) Anti-PD-1/PD-L1 naïve HCC	—	11.5 Percentage of participants Interval 2.4 to 30.2	—	—
Objective Response Rate (ORR) Anti-PD-1/PD-L1 R/R HCC	—	9.5 Percentage of participants Interval 1.2 to 30.4	—	—
Objective Response Rate (ORR) Anti-PD-1/PD-L1 naïve G/GEJ cancer	—	16.1 Percentage of participants Interval 5.5 to 33.7	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 years and 1 month

Population: The Efficacy Evaluable Analysis Set includes all participants who received ≥ 1 dose of any study drug with measurable disease at baseline per RECIST v1.1 and who had ≥ 1 evaluable postbaseline tumor assessment unless treatment was discontinued due to clinical progression or early death (within 13 weeks after the first dose date) before tumor assessment

DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease as assessed by investigator per RECIST v1.1, or death, whichever comes first. Results are reported for indication groups with responders, defined as complete response (CR) or partial response (PR). Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=5 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=10 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Duration of Response (DOR) Anti-PD-1/PD-L1 naïve or R/R HCC	7.7 Months Interval 2.8 to NA = not estimable due to low number of participants with events	—	—	—
Duration of Response (DOR) Anti-PD-1/PD-L1 naïve HCC	—	5.7 Months Interval 4.1 to NA = not estimable due to low number of participants with events	—	—
Duration of Response (DOR) Anti-PD-1/PD-L1 R/R HCC	—	NA Months Interval 5.4 to NA = not estimable due to low number of participants with events	—	—
Duration of Response (DOR) Anti-PD-1/PD-L1 naïve G/GEJ cancer	—	5.5 Months Interval 2.7 to NA = not estimable due to low number of participants with events	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 years and 1 month

Population: The Efficacy Evaluable Analysis Set includes all participants who received ≥ 1 dose of any study drug with measurable disease at baseline per RECIST v1.1 and who had ≥ 1 evaluable postbaseline tumor assessment unless treatment was discontinued due to clinical progression or early death (within 13 weeks after the first dose date) before tumor assessment

DCR is defined as the percentage of participants with BOR as CR, PR, or stable disease (SD) assessed by investigator per RECIST v1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=20 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=78 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Disease Control Rate (DCR) Anti-PD-1/PD-L1 naïve or R/R HCC	90.0 Percentage of participants Interval 68.3 to 98.8	—	—	—
Disease Control Rate (DCR) Anti-PD-1/PD-L1 naïve HCC	—	84.6 Percentage of participants Interval 65.1 to 95.6	—	—
Disease Control Rate (DCR) Anti-PD-1/PD-L1 R/R HCC	—	81.0 Percentage of participants Interval 58.1 to 94.6	—	—
Disease Control Rate (DCR) Anti-PD-1/PD-L1 naïve G/GEJ cancer	—	71.0 Percentage of participants Interval 52.0 to 85.8	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 years and 1 month

Population: The Safety Analysis Set includes all participants who received ≥ 1 dose of any study drug

PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. Safety analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=24 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=83 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Progression-free Survival (PFS) Anti-PD-1/PD-L1 naïve or R/R HCC	6.8 Months Interval 4.0 to 7.4	—	—	—
Progression-free Survival (PFS) Anti-PD-1/PD-L1 naïve HCC	—	6.8 Months Interval 2.8 to 8.3	—	—
Progression-free Survival (PFS) Anti-PD-1/PD-L1 R/R HCC	—	4.2 Months Interval 2.7 to 6.8	—	—
Progression-free Survival (PFS) Anti-PD-1/PD-L1 naïve G/GEJ cancer	—	3.6 Months Interval 2.8 to 4.7	—	—

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21) (21 days in each cycle)

Population: The Sitravatinib Pharmacokinetic (PK) Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=4 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=13 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Maximum Plasma Concentration (Cmax) for Sitravatinib C1D1	27.11 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 38.968	45.47 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 67.213	37.02 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 94.990	51.07 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 52.218
Maximum Plasma Concentration (Cmax) for Sitravatinib C1D21	63.98 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 3.060	69.30 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 78.298	56.01 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 103.431	62.38 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 54.927

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=4 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=13 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Time to Maximum Plasma Concentration (Tmax) for Sitravatinib C1D1	10.0 Hours (h) Interval 6.0 to 10.0	7.04 Hours (h) Interval 4.0 to 10.0	10.0 Hours (h) Interval 6.0 to 10.0	7.58 Hours (h) Interval 1.8 to 12.4
Time to Maximum Plasma Concentration (Tmax) for Sitravatinib C1D21	6.00 Hours (h) Interval 6.0 to 12.0	3.04 Hours (h) Interval 2.0 to 4.1	6.00 Hours (h) Interval 0.5 to 10.0	9.15 Hours (h) Interval 0.0 to 12.4

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=4 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=13 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib C1D1	397.95 h*ng/mL Geometric Coefficient of Variation 25.561	761.95 h*ng/mL Geometric Coefficient of Variation 62.680	604.63 h*ng/mL Geometric Coefficient of Variation 118.143	840.74 h*ng/mL Geometric Coefficient of Variation 59.869
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib C1D21	1276.52 h*ng/mL Geometric Coefficient of Variation 3.498	1364.56 h*ng/mL Geometric Coefficient of Variation 116.841	1095.90 h*ng/mL Geometric Coefficient of Variation 119.358	1089.57 h*ng/mL Geometric Coefficient of Variation 91.752

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=1 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=1 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=6 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Clearance After Oral Administration (CL/F) for Sitravatinib C1D1	92.58 Liters/hour Geometric Coefficient of Variation NA NA = not estimable due to single participant	35.23 Liters/hour Geometric Coefficient of Variation NA NA = not estimable due to single participant	—	82.77 Liters/hour Geometric Coefficient of Variation 62.096
Clearance After Oral Administration (CL/F) for Sitravatinib C1D21	63.76 Liters/hour Geometric Coefficient of Variation 5.016	—	29.14 Liters/hour Geometric Coefficient of Variation NA NA = not estimable due to single participant	78.31 Liters/hour Geometric Coefficient of Variation 44.296

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=2 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=1 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=6 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib C1D21	1254.71 h*ng/mL Geometric Coefficient of Variation 5.016	—	2745.23 h*ng/mL Geometric Coefficient of Variation NA NA = not estimable due to single participant	1532.33 h*ng/mL Geometric Coefficient of Variation 44.296
Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib C1D1	535.82 h*ng/mL Geometric Coefficient of Variation NA NA = not estimable due to single participant	686.11 h*ng/mL Geometric Coefficient of Variation 122.918	—	639.49 h*ng/mL Geometric Coefficient of Variation 63.908

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=1 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=2 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Observed Accumulation Ratio (Ro) for AUC(0-tau) for Sitravatinib	NA Ratio NA = not estimable due to low number of participants with events	—	—	3.94 Ratio Interval 0.09 to 165.95

SECONDARY outcome

Timeframe: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=2 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 Participants Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=8 Participants Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib	2.36 Ratio Interval 0.99 to 5.63	2.12 Ratio Interval 0.72 to 6.25	1.51 Ratio Interval 0.92 to 2.48	1.48 Ratio Interval 0.89 to 2.47

SECONDARY outcome

Timeframe: Predose and 6 hours postdose in Cycle 5 Day 1 (21 days in each cycle)

Population: The Sitravatinib PK Analysis Set includes all participants who contributed ≥ 1 quantifiable PK sample for sitravatinib

Outcome measures

Measure	Sitravatinib Monotherapy: 80 mg n=5 Participants Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=19 Participants Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Plasma Concentrations of Sitravatinib Predose: Anti-PD-1/PD-L1 naïve or R/R HCC	31.64 ng/mL Geometric Coefficient of Variation 18.492	—	—	—
Plasma Concentrations of Sitravatinib Postdose: Anti-PD-1/PD-L1 naïve or R/R HCC	48.12 ng/mL Geometric Coefficient of Variation 34.581	—	—	—
Plasma Concentrations of Sitravatinib Predose: Anti-PD-1/PD-L1 naïve HCC	—	23.54 ng/mL Geometric Coefficient of Variation 1435.332	—	—
Plasma Concentrations of Sitravatinib Postdose: Anti-PD-1/PD-L1 naïve HCC	—	77.40 ng/mL Geometric Coefficient of Variation 65.582	—	—
Plasma Concentrations of Sitravatinib Predose: Anti-PD-1/PD-L1 R/R HCC	—	35.95 ng/mL Geometric Coefficient of Variation 91.411	—	—
Plasma Concentrations of Sitravatinib Postdose: Anti-PD-1/PD-L1 R/R HCC	—	54.05 ng/mL Geometric Coefficient of Variation 49.017	—	—
Plasma Concentrations of Sitravatinib Predose: Anti-PD-1/PD-L1 naïve G/GEJ cancer	—	31.13 ng/mL Geometric Coefficient of Variation 66.433	—	—
Plasma Concentrations of Sitravatinib Postdose: Anti-PD-1/PD-L1 naïve G/GEJ cancer	—	42.22 ng/mL Geometric Coefficient of Variation 32.131	—	—

Adverse Events

Sitravatinib Monotherapy: 80 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Sitravatinib Monotherapy: 120 mg

Serious events: 7 serious events

Other events: 24 other events

Deaths: 12 deaths

Sitravatinib 80 mg + Tislelizumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Sitravatinib 120 mg + Tislelizumab

Serious events: 31 serious events

Other events: 78 other events

Deaths: 53 deaths

Serious adverse events

Measure	Sitravatinib Monotherapy: 80 mg n=3 participants at risk Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=24 participants at risk Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 participants at risk Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=81 participants at risk Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Blood and lymphatic system disorders Hypersplenism	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Myocardial infarction	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Ileus	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Death	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Fatigue	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Pyrexia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Sepsis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Septic shock	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Tuberculosis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood bilirubin increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Myocardial necrosis marker increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Platelet count decreased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Nervous system disorders Immune-mediated encephalitis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Nervous system disorders Loss of consciousness	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Renal and urinary disorders Nephrotic syndrome	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Vascular disorders Venous thrombosis limb	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month

Other adverse events

Measure	Sitravatinib Monotherapy: 80 mg n=3 participants at risk Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib Monotherapy: 120 mg n=24 participants at risk Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 80 mg + Tislelizumab n=3 participants at risk Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer	Sitravatinib 120 mg + Tislelizumab n=81 participants at risk Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	20.8% 5/24 • Number of events 9 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	27.2% 22/81 • Number of events 35 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Blood and lymphatic system disorders Hypersplenism	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Blood and lymphatic system disorders Splenomegaly	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Extrasystoles	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Supraventricular extrasystoles	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Cardiac disorders Ventricular extrasystoles	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Ear and labyrinth disorders Deafness	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Endocrine disorders Hyperthyroidism	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Endocrine disorders Hypothyroidism	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	19.8% 16/81 • Number of events 16 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	16.7% 4/24 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	16.7% 4/24 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	16.0% 13/81 • Number of events 15 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Ascites	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Constipation	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	58.3% 14/24 • Number of events 27 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 27/81 • Number of events 51 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Duodenitis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Gingival pain	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.3% 10/81 • Number of events 12 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Oral pain	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Retching	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Toothache	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	16.0% 13/81 • Number of events 14 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Asthenia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 9 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Chest discomfort	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Fatigue	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	11.1% 9/81 • Number of events 9 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Influenza like illness	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Malaise	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Peripheral swelling	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
General disorders Pyrexia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 8 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Hepatobiliary disorders Portal hypertension	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Influenza	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	54.2% 13/24 • Number of events 23 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	100.0% 3/3 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	50.6% 41/81 • Number of events 71 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Alpha hydroxybutyrate dehydrogenase increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	11.1% 9/81 • Number of events 25 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	54.2% 13/24 • Number of events 22 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	100.0% 3/3 • Number of events 6 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	50.6% 41/81 • Number of events 78 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Bilirubin conjugated increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	7.4% 6/81 • Number of events 9 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	18.5% 15/81 • Number of events 21 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood bilirubin increased	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	23.5% 19/81 • Number of events 29 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood bilirubin unconjugated increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood creatine phosphokinase MB increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	30.9% 25/81 • Number of events 55 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	18.5% 15/81 • Number of events 36 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood creatinine increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	6.2% 5/81 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood fibrinogen increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 6 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	14.8% 12/81 • Number of events 27 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood pressure increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	17.3% 14/81 • Number of events 18 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations C-reactive protein increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 11 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Fibrin D dimer increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	20.8% 5/24 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	17.3% 14/81 • Number of events 25 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Myocardial necrosis marker increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	6.2% 5/81 • Number of events 12 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Neutrophil count increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Platelet count decreased	66.7% 2/3 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	41.7% 10/24 • Number of events 13 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	27.2% 22/81 • Number of events 40 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Thyroglobulin decreased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Thyroxine free decreased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	6.2% 5/81 • Number of events 6 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Urinary occult blood positive	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	6.2% 5/81 • Number of events 10 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations Weight decreased	100.0% 3/3 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	25.0% 6/24 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	17.3% 14/81 • Number of events 17 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations White blood cell count decreased	33.3% 1/3 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	16.7% 4/24 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	17.3% 14/81 • Number of events 31 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Investigations White blood cell count increased	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	21.0% 17/81 • Number of events 18 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	1.2% 1/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	7.4% 6/81 • Number of events 10 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.5% 3/24 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	42.0% 34/81 • Number of events 44 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	9.9% 8/81 • Number of events 9 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypokalaemia	66.7% 2/3 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	20.8% 5/24 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	11.1% 9/81 • Number of events 22 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	12.3% 10/81 • Number of events 11 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	6.2% 5/81 • Number of events 6 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 9 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Musculoskeletal and connective tissue disorders Flank pain	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Nervous system disorders Vertebral artery occlusion	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Nervous system disorders Vertebral artery stenosis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	2.5% 2/81 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Renal and urinary disorders Haematuria	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	3.7% 3/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Renal and urinary disorders Nephrotic syndrome	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Renal and urinary disorders Proteinuria	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	54.2% 13/24 • Number of events 24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	54.3% 44/81 • Number of events 69 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Renal and urinary disorders Renal impairment	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Renal and urinary disorders Urinary retention	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.9% 4/81 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	20.8% 5/24 • Number of events 7 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	9.9% 8/81 • Number of events 10 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	6.2% 5/81 • Number of events 5 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	66.7% 2/3 • Number of events 2 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	70.8% 17/24 • Number of events 20 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	38.3% 31/81 • Number of events 32 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.3% 2/24 • Number of events 4 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	8.6% 7/81 • Number of events 8 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Vascular disorders Aortic thrombosis	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	4.2% 1/24 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Vascular disorders Hypertension	100.0% 3/3 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	16.7% 4/24 • Number of events 11 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	66.7% 2/3 • Number of events 3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	34.6% 28/81 • Number of events 32 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month
Vascular disorders Venous thrombosis limb	0.00% 0/3 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/24 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	33.3% 1/3 • Number of events 1 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month	0.00% 0/81 • From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month

Additional Information

Study Director

BeiGene

Phone: 1-877-828-5568

Email: clinicaltrials@beigene.com

Results disclosure agreements

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

Restriction type: OTHER