Tislelizumab Combined With Chemotherapy Versus Chemothera... | NCT03924986

ID	Type	Description	Link
CTR20182534	Registry Identifier	ChinaDrugTrials

Label	Type	Description	Intervention Names
Arm A: Tislelizumab + Gemcitabine + Cisplatin	Experimental	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.	Drug: Tislelizumab Drug: Gemcitabine Drug: Cisplatin
Arm B: Placebo + Gemcitabine + Cisplatin	Placebo Comparator	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.	Drug: Placebo Drug: Gemcitabine Drug: Cisplatin

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab	Drug	200 mg intravenously (IV) once every 3 weeks (Q3W)	Arm A: Tislelizumab + Gemcitabine + Cisplatin

Measure	Description	Time Frame
Progression-free Survival as Assessed by the Independent Review Committee (IRC)	Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS.	Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months)

Measure	Description	Time Frame
Overall Response Rate (ORR) as Assessed by the IRC	Defined as the percentage of participants who had complete response or partial response as assessed by the IRC per RECIST v1.1 in all randomized participants with measurable disease at Baseline.	Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months)

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Hospital		Hefei	Anhui	230000	China
Beijing Cancer Hospital

PubMed Identifier	Type	Citation
	Background	Zhang L, Liu T, Wang H, Shi S, Yang Y. A Phase 3 Trial in Progress Comparing Tislelizumab Plus Chemotherapy With Placebo Plus Chemotherapy in Chinese Patients With Recurrent or Metastatic Nasopharyngeal Cancer. Abstract published at: 22nd Annual Meeting of the Chinese Society of Clinical Oncology; September, 2019; Xiamen, China.
41746630	Derived	Yang Y, Yen CJ, Pan J, Wang H, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Wu Y, Yuan S, Chen C, Xu X, Ma X, Leaw S, Zhang L, Fang W. First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial. JAMA Oncol. 2026 Apr 1;12(4):384-393. doi: 10.1001/jamaoncol.2026.0020.
38671587

ID	Title	Description
FG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 26, 2021	Oct 18, 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

Progression-free Survival as Assessed by the Independent Review Committee (IRC)

Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS.

ITT analysis set

Posted

Median

95% Confidence Interval

Months

Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.

Units	Counts
Participants	OG000131 OG001132

Title

Denominators

Categories

Title	Measurements
	OG0009.2(7.6 to 10.1) OG0017.4(5.6 to 7.5)

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	The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.					Hazard Ratio (HR)	0.52			2-Sided	95	0.38	0.73			Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.		Other

Secondary

Overall Response Rate (ORR) as Assessed by the IRC

Defined as the percentage of participants who had complete response or partial response as assessed by the IRC per RECIST v1.1 in all randomized participants with measurable disease at Baseline.

ITT analysis set

Posted

Number

95% Confidence Interval

percentage of participants

Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.

Secondary

Duration of Response (DOR) as Assessed by the IRC

Defined as the time from the first occurrence of a documented objective response to the time of relapse, or death from any cause, whichever occurred first, as assessed by the IRC per RECIST v1.1 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.

Posted

Median

95% Confidence Interval

months

Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.

Secondary

Overall Survival (OS) as Assessed by the IRC

Defined as the time from the date of randomization to the date of death due to any cause.

ITT analysis set

Posted

Median

95% Confidence Interval

Months

Through study completion data cut-off date of December 8th, 2023 or last available date showing participants alive (maximum time on study follow-up was 53 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.

Secondary

PFS as Assessed by the Investigator

Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1.

ITT analysis set

Posted

Median

95% Confidence Interval

months

Through the interim analysis data cut-off date of March 26th, 2021 (up to approximately 23 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.

Secondary

Progression-free Survival After Next Line of Treatment (PFS2) as Assessed by the Investigator

Defined as the time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

ITT analysis set

Posted

Median

95% Confidence Interval

months

Through the study completion data cut-off date of December 8th, 2023 (maximum time on study follow-up was 53 months)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.

Secondary

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status

Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

The HRQoL analysis set includes all randomized participants who received any dose of study drug and completed at least one HRQoL assessment. Only participants with data at both baseline and the each postbaseline visit are included in the summary statistics for change from baseline.

Posted

Mean

Standard Deviation

score on a scale

Baseline to Cycle 6 (Each cycle is 21 days)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin

Secondary

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck-351 (EORTC QLQ-H&N35) Index Score

The QLQ-H&N35 consists of thirty-five questions that are associated with eighteen symptom scales (pain, swallowing, senses, speech, social eating, social contact, sexuality, problem with teeth, problem opening mouth, dry mouth, problem with sense smell, cough, felt ill, pain med, nutritional supplements, feeding tube, weight loss and weight gain).. Raw scores are transformed into a 0 to 100 scale via linear transformation. The index score is calculated as an average of the 18 symptom scales. A negative change from baseline score indicates improvement in symptoms.

Posted

Mean

Standard Deviation

score on a scale

Baseline to Cycle 6 (Each cycle is 21 days)

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.

Secondary

Number of Participants With Adverse Events

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations (PEs ), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. For Arm B, only adverse events reported prior to participants crossing over to receive tislelizumab monotherapy are included.

The Safety analysis set includes all randomized participants who received any dose of any component of study drug. Two participants randomized to Arm B who received 100 mg tislelizumab in error were analyzed as part of Arm A for the Safety Analysis Set.

Posted

Count of Participants

Participants

From first dose to 30 days after last dose or new anticancer therapy, or until Dec 8, 2023 data cut-off; max treatment duration: 231 weeks (Arm A), 202 weeks (Arm B).

ID	Title	Description
OG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
OG001	Arm B: Placebo + Gemcitabine + Cisplatin

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected133 at risk EG0015 events5 affected130 at risk EG0021 events1 affected70 at risk
Febrile neutropenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Leukopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0015 events4 affected130 at risk EG0020 events0 affected70 at risk
Myelosuppression	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Neutropenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0013 events2 affected130 at risk EG0020 events0 affected70 at risk
Thrombocytopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0014 events3 affected130 at risk EG0020 events0 affected70 at risk
Arrhythmia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Cardiac failure	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Myocarditis	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Supraventricular extrasystoles	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Ventricular arrhythmia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Ventricular extrasystoles	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Hypoacusis	Ear and labyrinth disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Dysphagia	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0021 events1 affected70 at risk
Gastritis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Nausea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Stomatitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected130 at risk EG0021 events1 affected70 at risk
Accidental death	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Death	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Generalised oedema	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Pyrexia	General disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Bile duct stone	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Cholecystitis	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Cholecystitis chronic	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Drug-induced liver injury	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Hepatic function abnormal	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Hepatic pain	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Cellulitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Complicated appendicitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Enterocolitis infectious	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Erysipelas	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Gingivitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Herpes zoster	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Infectious pleural effusion	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0014 events4 affected130 at risk EG0022 events1 affected70 at risk
Pneumonia aspiration	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0021 events1 affected70 at risk
Sepsis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0005 events4 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Urinary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Concussion	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Contusion	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Facial bones fracture	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Osteoradionecrosis	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Rib fracture	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Alanine aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Blood creatine phosphokinase increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events1 affected130 at risk EG0020 events0 affected70 at risk
Blood creatinine increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Lymphocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Monocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Neutrophil count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events3 affected133 at risk EG0018 events6 affected130 at risk EG0020 events0 affected70 at risk
Platelet count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00012 events9 affected133 at risk EG00116 events14 affected130 at risk EG0020 events0 affected70 at risk
Troponin increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events1 affected130 at risk EG0020 events0 affected70 at risk
White blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events3 affected133 at risk EG0016 events5 affected130 at risk EG0020 events0 affected70 at risk
Feeding disorder	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Hypercalcaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Hypernatraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected130 at risk EG0020 events0 affected70 at risk
Hyponatraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected130 at risk EG0021 events1 affected70 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Myositis	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Ataxia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Brain oedema	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Cerebral infarction	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0022 events2 affected70 at risk
Depressed level of consciousness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Dizziness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Headache	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Seizure	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Spinal cord compression	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Syncope	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Confusional state	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Acute kidney injury	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0021 events1 affected70 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Rash	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 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	EG000273 events114 affected133 at risk EG001235 events117 affected130 at risk EG00240 events19 affected70 at risk
Leukopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG000281 events46 affected133 at risk EG001204 events44 affected130 at risk EG0026 events2 affected70 at risk
Myelosuppression	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Neutropenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG000218 events46 affected133 at risk EG001159 events38 affected130 at risk EG0028 events1 affected70 at risk
Thrombocytopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG00051 events14 affected133 at risk EG00143 events16 affected130 at risk EG0021 events1 affected70 at risk
Hypoacusis	Ear and labyrinth disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0015 events5 affected130 at risk EG0020 events0 affected70 at risk
Middle ear inflammation	Ear and labyrinth disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected133 at risk EG0015 events4 affected130 at risk EG0021 events1 affected70 at risk
Tinnitus	Ear and labyrinth disorders	meddra 26.0	Systematic Assessment	EG00012 events11 affected133 at risk EG0018 events8 affected130 at risk EG0021 events1 affected70 at risk
Hyperthyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Hypothyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG00070 events41 affected133 at risk EG00123 events20 affected130 at risk EG00215 events11 affected70 at risk
Abdominal discomfort	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00019 events9 affected133 at risk EG00112 events8 affected130 at risk EG0020 events0 affected70 at risk
Abdominal distension	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00025 events18 affected133 at risk EG00119 events15 affected130 at risk EG0022 events2 affected70 at risk
Abdominal pain	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00012 events10 affected133 at risk EG00114 events9 affected130 at risk EG0023 events3 affected70 at risk
Abdominal pain upper	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected133 at risk EG00117 events9 affected130 at risk EG0020 events0 affected70 at risk
Constipation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG000108 events46 affected133 at risk EG001130 events60 affected130 at risk EG00212 events11 affected70 at risk
Diarrhoea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00026 events21 affected133 at risk EG00128 events14 affected130 at risk EG0023 events3 affected70 at risk
Dry mouth	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00021 events17 affected133 at risk EG0019 events6 affected130 at risk EG0022 events2 affected70 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0007 events6 affected133 at risk EG0014 events3 affected130 at risk EG0020 events0 affected70 at risk
Gingival pain	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0009 events7 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Mouth ulceration	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00023 events10 affected133 at risk EG0013 events3 affected130 at risk EG0020 events0 affected70 at risk
Nausea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG000206 events78 affected133 at risk EG001263 events94 affected130 at risk EG0026 events6 affected70 at risk
Stomatitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00010 events5 affected133 at risk EG0019 events7 affected130 at risk EG0021 events1 affected70 at risk
Toothache	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00011 events9 affected133 at risk EG0014 events4 affected130 at risk EG0029 events6 affected70 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG000122 events55 affected133 at risk EG001175 events68 affected130 at risk EG0024 events4 affected70 at risk
Asthenia	General disorders	meddra 26.0	Systematic Assessment	EG00017 events13 affected133 at risk EG00112 events11 affected130 at risk EG0021 events1 affected70 at risk
Chest discomfort	General disorders	meddra 26.0	Systematic Assessment	EG00011 events9 affected133 at risk EG00112 events8 affected130 at risk EG0021 events1 affected70 at risk
Chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0012 events2 affected130 at risk EG0020 events0 affected70 at risk
Fatigue	General disorders	meddra 26.0	Systematic Assessment	EG00028 events17 affected133 at risk EG00126 events17 affected130 at risk EG0021 events1 affected70 at risk
Influenza like illness	General disorders	meddra 26.0	Systematic Assessment	EG0006 events4 affected133 at risk EG0016 events4 affected130 at risk EG0023 events2 affected70 at risk
Malaise	General disorders	meddra 26.0	Systematic Assessment	EG00070 events29 affected133 at risk EG00162 events31 affected130 at risk EG0025 events5 affected70 at risk
Non-cardiac chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0007 events4 affected133 at risk EG0015 events4 affected130 at risk EG0022 events2 affected70 at risk
Oedema peripheral	General disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected133 at risk EG00115 events8 affected130 at risk EG0020 events0 affected70 at risk
Pyrexia	General disorders	meddra 26.0	Systematic Assessment	EG00046 events34 affected133 at risk EG00120 events13 affected130 at risk EG0023 events3 affected70 at risk
Drug-induced liver injury	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected133 at risk EG00112 events4 affected130 at risk EG0022 events1 affected70 at risk
Hepatic function abnormal	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG00012 events6 affected133 at risk EG00110 events6 affected130 at risk EG0020 events0 affected70 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0007 events4 affected133 at risk EG0014 events1 affected130 at risk EG00213 events7 affected70 at risk
Nasopharyngitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0006 events5 affected133 at risk EG0014 events4 affected130 at risk EG0024 events3 affected70 at risk
Otitis media	Infections and infestations	meddra 26.0	Systematic Assessment	EG0007 events7 affected133 at risk EG0013 events2 affected130 at risk EG0023 events3 affected70 at risk
Periodontitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG00010 events10 affected133 at risk EG0013 events3 affected130 at risk EG0023 events3 affected70 at risk
Upper respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG00032 events22 affected133 at risk EG00115 events12 affected130 at risk EG0029 events6 affected70 at risk
Urinary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0007 events6 affected133 at risk EG0014 events4 affected130 at risk EG0022 events1 affected70 at risk
Alanine aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00059 events36 affected133 at risk EG00141 events26 affected130 at risk EG00211 events11 affected70 at risk
Alpha hydroxybutyrate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG00011 events7 affected133 at risk EG0012 events2 affected130 at risk EG0024 events2 affected70 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00065 events38 affected133 at risk EG00147 events30 affected130 at risk EG00214 events11 affected70 at risk
Blood albumin decreased	Investigations	meddra 26.0	Systematic Assessment	EG0005 events5 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Blood alkaline phosphatase increased	Investigations	meddra 26.0	Systematic Assessment	EG00011 events8 affected133 at risk EG0018 events4 affected130 at risk EG0023 events3 affected70 at risk
Blood bilirubin increased	Investigations	meddra 26.0	Systematic Assessment	EG00022 events8 affected133 at risk EG00110 events8 affected130 at risk EG0022 events1 affected70 at risk
Blood cholesterol increased	Investigations	meddra 26.0	Systematic Assessment	EG0009 events4 affected133 at risk EG0012 events2 affected130 at risk EG0020 events0 affected70 at risk
Blood creatine phosphokinase MB increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0012 events2 affected130 at risk EG0022 events1 affected70 at risk
Blood creatine phosphokinase increased	Investigations	meddra 26.0	Systematic Assessment	EG00022 events11 affected133 at risk EG0014 events3 affected130 at risk EG00211 events6 affected70 at risk
Blood creatinine increased	Investigations	meddra 26.0	Systematic Assessment	EG00060 events32 affected133 at risk EG00141 events22 affected130 at risk EG0028 events5 affected70 at risk
Blood lactate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG00021 events13 affected133 at risk EG0019 events8 affected130 at risk EG0025 events3 affected70 at risk
Blood thyroid stimulating hormone increased	Investigations	meddra 26.0	Systematic Assessment	EG00011 events8 affected133 at risk EG0018 events7 affected130 at risk EG0023 events3 affected70 at risk
Blood urea increased	Investigations	meddra 26.0	Systematic Assessment	EG00018 events9 affected133 at risk EG00110 events8 affected130 at risk EG0021 events1 affected70 at risk
Creatinine renal clearance decreased	Investigations	meddra 26.0	Systematic Assessment	EG0007 events5 affected133 at risk EG0013 events2 affected130 at risk EG0020 events0 affected70 at risk
Fibrin D dimer increased	Investigations	meddra 26.0	Systematic Assessment	EG0005 events4 affected133 at risk EG0014 events4 affected130 at risk EG0020 events0 affected70 at risk
Gamma-glutamyltransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00011 events9 affected133 at risk EG0018 events4 affected130 at risk EG0023 events3 affected70 at risk
Granulocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0008 events4 affected133 at risk EG0015 events2 affected130 at risk EG0020 events0 affected70 at risk
Haemoglobin decreased	Investigations	meddra 26.0	Systematic Assessment	EG0006 events5 affected133 at risk EG0014 events2 affected130 at risk EG0020 events0 affected70 at risk
Lymphocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00052 events19 affected133 at risk EG00163 events23 affected130 at risk EG00213 events3 affected70 at risk
Monocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00012 events7 affected133 at risk EG0014 events4 affected130 at risk EG0020 events0 affected70 at risk
Monocyte percentage decreased	Investigations	meddra 26.0	Systematic Assessment	EG0006 events4 affected133 at risk EG0011 events1 affected130 at risk EG0020 events0 affected70 at risk
Neutrophil count decreased	Investigations	meddra 26.0	Systematic Assessment	EG000294 events80 affected133 at risk EG001306 events76 affected130 at risk EG00220 events6 affected70 at risk
Neutrophil count increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0012 events2 affected130 at risk EG0020 events0 affected70 at risk
Platelet count decreased	Investigations	meddra 26.0	Systematic Assessment	EG000160 events68 affected133 at risk EG001202 events76 affected130 at risk EG0021 events1 affected70 at risk
Platelet count increased	Investigations	meddra 26.0	Systematic Assessment	EG00013 events6 affected133 at risk EG00110 events5 affected130 at risk EG0020 events0 affected70 at risk
Red blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0008 events5 affected133 at risk EG0013 events3 affected130 at risk EG0022 events1 affected70 at risk
Thyroxine free decreased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events3 affected133 at risk EG0013 events2 affected130 at risk EG0023 events3 affected70 at risk
Weight decreased	Investigations	meddra 26.0	Systematic Assessment	EG00020 events19 affected133 at risk EG00115 events14 affected130 at risk EG0022 events1 affected70 at risk
White blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG000393 events81 affected133 at risk EG001454 events81 affected130 at risk EG00228 events8 affected70 at risk
Decreased appetite	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG000119 events64 affected133 at risk EG001132 events65 affected130 at risk EG0024 events4 affected70 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00013 events5 affected133 at risk EG0017 events4 affected130 at risk EG0020 events0 affected70 at risk
Hyperglycaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00013 events7 affected133 at risk EG0014 events4 affected130 at risk EG0021 events1 affected70 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00018 events12 affected133 at risk EG00112 events6 affected130 at risk EG0020 events0 affected70 at risk
Hyperuricaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00074 events24 affected133 at risk EG00153 events25 affected130 at risk EG00223 events7 affected70 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00039 events22 affected133 at risk EG00144 events29 affected130 at risk EG00217 events8 affected70 at risk
Hypocalcaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00040 events25 affected133 at risk EG00131 events17 affected130 at risk EG0021 events1 affected70 at risk
Hypochloraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00028 events16 affected133 at risk EG00146 events22 affected130 at risk EG0023 events2 affected70 at risk
Hypoglycaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00010 events6 affected133 at risk EG0010 events0 affected130 at risk EG0020 events0 affected70 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00047 events30 affected133 at risk EG00160 events29 affected130 at risk EG0029 events6 affected70 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00044 events22 affected133 at risk EG00123 events16 affected130 at risk EG0027 events4 affected70 at risk
Hyponatraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00075 events40 affected133 at risk EG00188 events36 affected130 at risk EG00213 events11 affected70 at risk
Hypophosphataemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00018 events8 affected133 at risk EG00115 events8 affected130 at risk EG00211 events2 affected70 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00018 events12 affected133 at risk EG00110 events7 affected130 at risk EG0027 events3 affected70 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG00032 events18 affected133 at risk EG00120 events17 affected130 at risk EG0026 events5 affected70 at risk
Back pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG00042 events23 affected133 at risk EG00122 events18 affected130 at risk EG0021 events1 affected70 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG00011 events9 affected133 at risk EG0016 events5 affected130 at risk EG0023 events3 affected70 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0004 events3 affected133 at risk EG0014 events4 affected130 at risk EG0020 events0 affected70 at risk
Neck pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0007 events5 affected133 at risk EG00112 events10 affected130 at risk EG0022 events2 affected70 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG00022 events17 affected133 at risk EG00110 events10 affected130 at risk EG0023 events2 affected70 at risk
Dizziness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG00042 events22 affected133 at risk EG00135 events19 affected130 at risk EG0022 events2 affected70 at risk
Headache	Nervous system disorders	meddra 26.0	Systematic Assessment	EG00022 events15 affected133 at risk EG00135 events22 affected130 at risk EG0027 events7 affected70 at risk
Hypoaesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG00037 events20 affected133 at risk EG00132 events20 affected130 at risk EG0024 events3 affected70 at risk
Peripheral sensory neuropathy	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected133 at risk EG0012 events2 affected130 at risk EG0021 events1 affected70 at risk
Insomnia	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG00017 events14 affected133 at risk EG00125 events17 affected130 at risk EG0022 events2 affected70 at risk
Haematuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected133 at risk EG0013 events2 affected130 at risk EG0020 events0 affected70 at risk
Proteinuria	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected133 at risk EG0016 events4 affected130 at risk EG0021 events1 affected70 at risk
Renal impairment	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0006 events5 affected133 at risk EG0015 events3 affected130 at risk EG0020 events0 affected70 at risk
Cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00039 events29 affected133 at risk EG00116 events13 affected130 at risk EG00214 events11 affected70 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0006 events5 affected133 at risk EG0013 events3 affected130 at risk EG0020 events0 affected70 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00011 events9 affected133 at risk EG00114 events12 affected130 at risk EG0022 events2 affected70 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00012 events7 affected133 at risk EG0013 events3 affected130 at risk EG0024 events4 affected70 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00034 events17 affected133 at risk EG00123 events10 affected130 at risk EG0020 events0 affected70 at risk
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected133 at risk EG0012 events2 affected130 at risk EG0021 events1 affected70 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00011 events7 affected133 at risk EG0012 events2 affected130 at risk EG0025 events3 affected70 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00014 events12 affected133 at risk EG00113 events10 affected130 at risk EG0024 events3 affected70 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG00026 events22 affected133 at risk EG00110 events10 affected130 at risk EG0026 events5 affected70 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0008 events8 affected133 at risk EG0012 events2 affected130 at risk EG0020 events0 affected70 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0012 events2 affected130 at risk EG0020 events0 affected70 at risk
Alopecia	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG00010 events10 affected133 at risk EG00111 events11 affected130 at risk EG0020 events0 affected70 at risk
Erythema	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected133 at risk EG0014 events4 affected130 at risk EG0020 events0 affected70 at risk
Pruritus	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG00074 events29 affected133 at risk EG00133 events18 affected130 at risk EG0029 events6 affected70 at risk
Rash	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG00054 events34 affected133 at risk EG00134 events29 affected130 at risk EG0026 events5 affected70 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0008 events4 affected133 at risk EG0017 events4 affected130 at risk EG0020 events0 affected70 at risk
Hypertension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0005 events5 affected133 at risk EG0017 events6 affected130 at risk EG0020 events0 affected70 at risk
Hypotension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected133 at risk EG0014 events4 affected130 at risk EG0020 events0 affected70 at risk
Phlebitis	Vascular disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected133 at risk EG0017 events5 affected130 at risk EG0020 events0 affected70 at risk

ID	Term
D012008	Recurrence
D009303	Nasopharyngeal Neoplasms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009302	Nasopharyngeal Diseases
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description
BG000	Arm A: Tislelizumab + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.
BG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.
BG002	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 + Gemcitabine + Cisplatin	Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy.	57	133	47	133	133	133
EG001	Arm B: Placebo + Gemcitabine + Cisplatin	Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy.	31	130	46	130	129	130
EG002	Post Crossover Tislelizumab	Participants in Arm B crossed over to receive tislelizumab 200 mg IV Q3W upon confirmed disease progression per RECIST v1.1 by the IRC, and with medical monitor approval.	35	70	15	70	60	70