Study To Investigate the Efficacy and Safety of Sitravati... | NCT05461794

ID	Type	Description	Link
CTR20222088	Other Identifier	ChinaDrugTrials

Label	Type	Description	Intervention Names
Arm A: Tislelizumab + Sitravatinib	Experimental	Sitravatinib administered orally and tislelizumab administered intravenously	Drug: Sitravatinib Drug: Tislelizumab
Arm B: Sitravatinib	Experimental	Sitravatinib administered orally	Drug: Sitravatinib
Arm C: Investigator-chosen chemotherapy (ICC)	Experimental	Investigators chose between docetaxel or irinotecan	Drug: Docetaxel Drug: Irinotecan

Name	Type	Description	Arm Group Labels	Other Names
Sitravatinib	Drug	100 mg orally once daily	Arm A: Tislelizumab + Sitravatinib Arm B: Sitravatinib

Measure	Description	Time Frame
Arms A and C: Overall Response Rate (ORR)	ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.	Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

Measure	Description	Time Frame
Duration of Response (DOR)	Defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator or death from any cause, whichever occurred first, in all randomized participants with documented objective responses.	Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Hospital South Brance		Hefei	Anhui	230036	China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

ID	Title	Description
FG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
FG001	Arm B: Sitravatinib

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 10, 2023	Nov 7, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Arms A and C: Overall Response Rate (ORR)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.

The Intent-to-Treat (ITT) analysis set included all randomized participants; for the primary analysis of ORR only Arms A and C were included, results for Arm B are included in the secondary Outcome Measures section.

Posted

Number

95% Confidence Interval

percentage of participants

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Units	Counts
Participants	OG00039 OG00138

Title

Denominators

Categories

Title	Measurements
	OG00010.3(2.9 to 24.2) OG0015.3(0.6 to 17.7)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Odds Ratio (OR)	2.1			2-Sided	95	0.3	23.9			The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.		Other
OG000 OG001

Secondary

Duration of Response (DOR)

Defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator or death from any cause, whichever occurred first, in all randomized participants with documented objective responses.

ITT analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders

Posted

Median

95% Confidence Interval

months

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
OG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Secondary

Overall Survival (OS)

Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.

ITT analysis set

Posted

Median

95% Confidence Interval

months

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
OG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Units	Counts

Secondary

Disease Control Rate (DCR)

Defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per RECIST v1.1

ITT analysis set

Posted

Number

95% Confidence Interval

percentage of participants

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
OG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Secondary

Clinical Benefit Rate (CBR)

Defined as the percentage of participants with a complete response, partial response, or durable stable disease (defined as stable disease for 24 weeks or longer, as assessed by the investigator per RECIST v.1.1.

ITT analysis set

Posted

Number

95% Confidence Interval

percentage of participants

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
OG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Secondary

Progression Free Survival (PFS)

Defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Kaplan-Meier methodology was used to estimate the median PFS.

ITT analysis set

Posted

Median

95% Confidence Interval

months

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
OG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Secondary

Arms A and B: Overall Response Rate (ORR)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1. Analysis of ORR in Arm A compared to Arm B was specified as a secondary endpoint in the Protocol (please see the primary outcome measure for Arm C results)

ITT analysis set for Arms A and B

Posted

Number

95% Confidence Interval

percentage of participants

Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Adverse Events

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

The Safety Analysis Set includes all participants who received at least 1 dose of any component of study treatments.

Posted

Count of Participants

Participants

From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).

ID	Title	Description
OG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
OG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
OG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Coagulopathy	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Acute coronary syndrome	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Cardiac failure	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Cardiogenic shock	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Cardiomyopathy	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Pericardial effusion	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Pericarditis	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Pneumopericardium	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Supraventricular extrasystoles	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Hypothyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Duodenitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0021 events1 affected34 at risk
Ileus	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Nausea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Obstruction gastric	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Oesophageal fistula	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Oesophageal obstruction	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0021 events1 affected34 at risk
Pancreatitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Chest discomfort	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Death	General disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Malaise	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Multiple organ dysfunction syndrome	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Hepatic failure	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Bacteraemia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
COVID-19 pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected19 at risk EG0021 events1 affected34 at risk
Pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0003 events3 affected39 at risk EG0011 events1 affected19 at risk EG0022 events2 affected34 at risk
Pneumonia bacterial	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Pneumonia fungal	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Postoperative wound infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Septic shock	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Skin infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Subcutaneous abscess	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Upper respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Neutrophil count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0023 events3 affected34 at risk
White blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0023 events3 affected34 at risk
Cachexia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Decreased appetite	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Metastases to soft tissue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Hepatic encephalopathy	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Hypoaesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Loss of consciousness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Acquired tracheo-oesophageal fistula	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Bronchial fistula	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Circulatory collapse	Vascular disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Hypertension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0021 events1 affected34 at risk
Shock	Vascular disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Shock haemorrhagic	Vascular disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG00018 events12 affected39 at risk EG0016 events5 affected19 at risk EG00223 events20 affected34 at risk
Lymphopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Aortic valve calcification	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Cardiac failure	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Left ventricular dysfunction	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Supraventricular tachycardia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Tricuspid valve incompetence	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Central hypothyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Hypothyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG00010 events9 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Abdominal discomfort	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Abdominal distension	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Abdominal pain	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Abdominal pain upper	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0006 events4 affected39 at risk EG0014 events3 affected19 at risk EG0022 events2 affected34 at risk
Chronic gastritis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Constipation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00011 events7 affected39 at risk EG0011 events1 affected19 at risk EG0026 events6 affected34 at risk
Diarrhoea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0006 events5 affected39 at risk EG0014 events3 affected19 at risk EG00228 events14 affected34 at risk
Dysphagia	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected19 at risk EG0021 events1 affected34 at risk
Gastritis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0023 events3 affected34 at risk
Nausea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected39 at risk EG0015 events4 affected19 at risk EG00214 events12 affected34 at risk
Oesophageal obstruction	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Stomatitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG00212 events10 affected34 at risk
Asthenia	General disorders	meddra 26.0	Systematic Assessment	EG0006 events6 affected39 at risk EG0015 events4 affected19 at risk EG0023 events3 affected34 at risk
Chest discomfort	General disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Fatigue	General disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected19 at risk EG0023 events2 affected34 at risk
Malaise	General disorders	meddra 26.0	Systematic Assessment	EG0004 events3 affected39 at risk EG0010 events0 affected19 at risk EG0023 events3 affected34 at risk
Oedema peripheral	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Pyrexia	General disorders	meddra 26.0	Systematic Assessment	EG0007 events5 affected39 at risk EG0010 events0 affected19 at risk EG0027 events5 affected34 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0005 events4 affected39 at risk EG0017 events2 affected19 at risk EG0028 events4 affected34 at risk
COVID-19 pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Nasopharyngitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected19 at risk EG0021 events1 affected34 at risk
Pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0024 events4 affected34 at risk
Upper respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Urinary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Alanine aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00022 events13 affected39 at risk EG0017 events6 affected19 at risk EG0029 events4 affected34 at risk
Alpha hydroxybutyrate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events3 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00025 events15 affected39 at risk EG00111 events9 affected19 at risk EG0022 events2 affected34 at risk
Bilirubin conjugated increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events1 affected19 at risk EG0022 events2 affected34 at risk
Blood alkaline phosphatase increased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events2 affected39 at risk EG0012 events1 affected19 at risk EG0024 events4 affected34 at risk
Blood bilirubin increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events3 affected39 at risk EG0011 events1 affected19 at risk EG0023 events3 affected34 at risk
Blood creatine phosphokinase MB increased	Investigations	meddra 26.0	Systematic Assessment	EG00011 events6 affected39 at risk EG0012 events2 affected19 at risk EG0021 events1 affected34 at risk
Blood creatine phosphokinase increased	Investigations	meddra 26.0	Systematic Assessment	EG0005 events3 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Blood creatinine increased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events2 affected39 at risk EG0010 events0 affected19 at risk EG0021 events1 affected34 at risk
Blood lactate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG0008 events6 affected39 at risk EG0013 events2 affected19 at risk EG0021 events1 affected34 at risk
Blood potassium decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Blood pressure increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events4 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Blood thyroid stimulating hormone increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Blood urea increased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events1 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Electrocardiogram QT prolonged	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected19 at risk EG0020 events0 affected34 at risk
Fibrin D dimer increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0021 events1 affected34 at risk
Gamma-glutamyltransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events1 affected39 at risk EG0011 events1 affected19 at risk EG0022 events2 affected34 at risk
High density lipoprotein decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected19 at risk EG0020 events0 affected34 at risk
Lipoprotein increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Lymphocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events3 affected39 at risk EG0010 events0 affected19 at risk EG0026 events5 affected34 at risk
Neutrophil count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events3 affected39 at risk EG00115 events5 affected19 at risk EG00248 events21 affected34 at risk
Neutrophil count increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Platelet count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00016 events9 affected39 at risk EG0019 events7 affected19 at risk EG00210 events6 affected34 at risk
Red blood cells urine positive	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected19 at risk EG0020 events0 affected34 at risk
SARS-CoV-2 test positive	Investigations	meddra 26.0	Systematic Assessment	EG0003 events3 affected39 at risk EG0012 events1 affected19 at risk EG0022 events2 affected34 at risk
Urinary occult blood positive	Investigations	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events1 affected19 at risk EG0020 events0 affected34 at risk
Urobilinogen urine increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Weight decreased	Investigations	meddra 26.0	Systematic Assessment	EG00011 events10 affected39 at risk EG0018 events7 affected19 at risk EG00212 events9 affected34 at risk
White blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00012 events7 affected39 at risk EG00115 events5 affected19 at risk EG00255 events24 affected34 at risk
White blood cell count increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Decreased appetite	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0008 events7 affected39 at risk EG0018 events6 affected19 at risk EG00212 events10 affected34 at risk
Hypercalcaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Hyperglycaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Hyperuricaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0005 events3 affected39 at risk EG0010 events0 affected19 at risk EG0023 events1 affected34 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00013 events10 affected39 at risk EG0016 events6 affected19 at risk EG00215 events8 affected34 at risk
Hypocalcaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0006 events4 affected39 at risk EG0012 events1 affected19 at risk EG0025 events5 affected34 at risk
Hypochloraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0005 events3 affected39 at risk EG0011 events1 affected19 at risk EG0021 events1 affected34 at risk
Hypoglycaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected19 at risk EG0021 events1 affected34 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00012 events7 affected39 at risk EG0016 events5 affected19 at risk EG00217 events9 affected34 at risk
Hyponatraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00010 events7 affected39 at risk EG0014 events3 affected19 at risk EG0024 events4 affected34 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Back pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Neck pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Dizziness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Headache	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Hypoaesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected19 at risk EG0022 events2 affected34 at risk
Peripheral sensory neuropathy	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Taste disorder	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Insomnia	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected39 at risk EG0010 events0 affected19 at risk EG0024 events3 affected34 at risk
Albuminuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Dysuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Proteinuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected19 at risk EG0022 events2 affected34 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00010 events8 affected39 at risk EG0013 events3 affected19 at risk EG0023 events3 affected34 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0006 events6 affected39 at risk EG0012 events2 affected19 at risk EG0020 events0 affected34 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected19 at risk EG0020 events0 affected34 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events1 affected19 at risk EG0020 events0 affected34 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected19 at risk EG0020 events0 affected34 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected39 at risk EG0010 events0 affected19 at risk EG0020 events0 affected34 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected39 at risk EG0011 events1 affected19 at risk EG0023 events3 affected34 at risk
Alopecia	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected19 at risk EG0023 events3 affected34 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG00010 events9 affected39 at risk EG00110 events8 affected19 at risk EG0020 events0 affected34 at risk
Rash	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected39 at risk EG0011 events1 affected19 at risk EG0022 events2 affected34 at risk
Hypertension	Vascular disorders	meddra 26.0	Systematic Assessment	EG00010 events8 affected39 at risk EG0014 events4 affected19 at risk EG0021 events1 affected34 at risk
Hypotension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0015 events1 affected19 at risk EG0022 events1 affected34 at risk

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018307	Neoplasms, Squamous Cell
D004938	Esophageal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D006258	Head and Neck Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
BG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.
BG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Tislelizumab + Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.	20	39	22	39	39	39
EG001	Arm B: Sitravatinib	Sitravatinib was administered orally at a dose of 100 mg once daily.	5	19	6	19	19	19
EG002	Arm C: Investigator-chosen Chemotherapy (ICC)	Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.	19	38	15	34	34	34

ID	Term
C000611865	sitravatinib
C000707970	tislelizumab
D000077143	Docetaxel
D000077146	Irinotecan