A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as... | NCT03430843

NCT03430843

ID	Type	Description	Link
2017-003699-30	EudraCT Number
CTR20171026	Registry Identifier	ChinaDrugTrials

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tislelizumab	Experimental	Tislelizumab on Day 1, given every 21 days	Drug: Tislelizumab
Investigator chosen chemotherapy (ICC)	Active Comparator	Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days	Drug: Paclitaxel Drug: Docetaxel Drug: Irinotecan

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab	Drug	200 mg administered intravenously (IV)	Tislelizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set	OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants	Approximately 2 years and 10 months from date of first randomization

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in the PDL-1 Positive Analysis Set	OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Objective Response Rate (ORR) in the ITT Analysis Set

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Hospital		Detroit	Michigan	48202	United States
Toledo Clinic Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35442766	Result	Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.
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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
FG001	Investigator Chosen Chemotherapy

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 20, 2020	Nov 10, 2023

Arm/Group Information

ID	Title	Description
BG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
BG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.8± 8.41 BG00161.8± 8.02 BG00261.8± 8.21

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00141 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Asian	BG000201 BG001207 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status Score

Measure Description: ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0	BG00066 BG001

PD-L1 Expression Status

Measure Description: Programmed death ligand 1 (PD-L1) positive is defined as visually-estimated Combined Positive Score (vCPS) >= 10%, PD-L1 negative is defined as vCPS < 10%, PD-L1 missing refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.

Note terminology was updated from vCPS to Tumor Area Positivity (TAP) score in manuscripts.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
vCPS >= 10%	BG00080 BG001

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

Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set

OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants

The ITT analysis set included all randomized participants

Posted

Median

95% Confidence Interval

Months

Approximately 2 years and 10 months from date of first randomization

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants	OG000256 OG001256

Title

Denominators

Categories

Title	Measurements
	OG0008.6(7.5 to 10.4) OG0016.3(5.3 to 7.0)

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		1-sided, Log Rank Test		0.0001		Hazard Ratio (HR)	0.70			2-Sided	95	0.57	0.85					Superiority

Secondary

Overall Survival (OS) in the PDL-1 Positive Analysis Set

OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.

The PD-L1 positive population included all randomized participants with tumor PD-L1 vCPS ≥10%

Posted

Median

95% Confidence Interval

Months

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Objective Response Rate (ORR) in the ITT Analysis Set

ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

The ITT analysis set included all randomized participants

Posted

Number

95% Confidence Interval

Percentage of Participants

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets

ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%

Posted

Number

95% Confidence Interval

Percentage of Participants

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Progression-free Survival (PFS) in the ITT Analysis Set

PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set

The ITT analysis set included all randomized participants

Posted

Median

95% Confidence Interval

Months

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%

Posted

Median

95% Confidence Interval

Months

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Duration of Response (DOR) in the ITT Analysis Set

DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first

The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis

Posted

Median

95% Confidence Interval

Months

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Duration of Response (DOR) in the PDL-1 Positive Analysis Set.

The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis

Posted

Median

95% Confidence Interval

Months

Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Secondary

Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set

Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. 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 ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Cycle 6 (21 days per cycle)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Secondary

HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set

Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. 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 PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Cycle 6 (21 days per cycle)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Secondary

HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set

Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes 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.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Cycle 6 (21 days per cycle)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Secondary

HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Cycle 6 (21 days per cycle)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Secondary

HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set

Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Cycle 6 (21 days per cycle)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Secondary

HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Cycle 6 (21 days per cycle)

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Secondary

Number of Participants Experiencing Adverse Events (AEs)

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs

Safety analysis set included all participants who received ≥ 1 dose of study drug

Posted

Number

Participants

From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months

ID	Title	Description
OG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
OG001	Investigator Chosen Chemotherapy	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tislelizumab	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	233	256	109	255	232	255
EG001	Investigator Chosen Chemotherapy (ICC)	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days	233	256	106	240	231	240

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0019 events3 affected240 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0019 events8 affected240 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0017 events4 affected240 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0014 events2 affected240 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Autoimmune myocarditis	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Cardiac arrest	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Immune-mediated myocarditis	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Myocardial infarction	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Pericardial effusion	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Hypothyroidism	Endocrine disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Colitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Constipation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0018 events8 affected240 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00016 events13 affected255 at risk EG0015 events4 affected240 at risk
Gastric fistula	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected240 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0014 events2 affected240 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Melaena	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Nausea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0016 events4 affected240 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Oesophageal fistula	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected240 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0006 events5 affected255 at risk EG0011 events1 affected240 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0004 events3 affected255 at risk EG0010 events0 affected240 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Oesophagomediastinal fistula	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected240 at risk
Rectal obstruction	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0004 events4 affected255 at risk EG0014 events4 affected240 at risk
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected240 at risk
Asthenia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Death	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0014 events4 affected240 at risk
Fatigue	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected240 at risk
General physical health deterioration	General disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events3 affected255 at risk EG0015 events4 affected240 at risk
Malaise	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected240 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (25.0)	Systematic Assessment	EG0004 events3 affected255 at risk EG0011 events1 affected240 at risk
Oedema peripheral	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Pyrexia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected240 at risk
Sudden death	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected240 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Anaphylactic shock	Immune system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Abscess neck	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Biliary tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Bronchitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Device related infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Peritonitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Pneumonia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG00024 events19 affected255 at risk EG00118 events17 affected240 at risk
Pneumonia aspiration	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0012 events1 affected240 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Respiratory tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Sepsis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0004 events2 affected255 at risk EG0011 events1 affected240 at risk
Septic shock	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0014 events4 affected240 at risk
Testicular abscess	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Vascular device infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Wound infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events2 affected240 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Tracheostomy malfunction	Injury, poisoning and procedural complications	MedDRA (25.0)	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected240 at risk
Lymphocyte count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Neutrophil count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG00114 events10 affected240 at risk
Platelet count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
White blood cell count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG00111 events8 affected240 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0016 events6 affected240 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0005 events2 affected255 at risk EG0010 events0 affected240 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0007 events4 affected255 at risk EG0010 events0 affected240 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected240 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events1 affected255 at risk EG0011 events1 affected240 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Immune-mediated myositis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0004 events2 affected255 at risk EG0010 events0 affected240 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Metastases to heart	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Tumour fistulisation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0014 events2 affected240 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0012 events1 affected240 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Ataxia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Brain oedema	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Cerebral infarction	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected240 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Spinal cord compression	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Syncope	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Delirium	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Nephroangiosclerosis	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Acquired tracheo-oesophageal fistula	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0014 events4 affected240 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected240 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0004 events3 affected255 at risk EG0012 events1 affected240 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected240 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events3 affected255 at risk EG0010 events0 affected240 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Oesophagobronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events1 affected255 at risk EG0012 events1 affected240 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events3 affected255 at risk EG0014 events4 affected240 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0005 events5 affected255 at risk EG0012 events2 affected240 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0006 events1 affected255 at risk EG0010 events0 affected240 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events2 affected255 at risk EG0011 events1 affected240 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected240 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected240 at risk
Tracheal fistula	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected240 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Hypotension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected240 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected240 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG000139 events80 affected255 at risk EG001192 events109 affected240 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG00019 events9 affected255 at risk EG00157 events29 affected240 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG00011 events2 affected255 at risk EG00156 events30 affected240 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0007 events5 affected255 at risk EG00113 events10 affected240 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (25.0)	Systematic Assessment	EG0008 events8 affected255 at risk EG0011 events1 affected240 at risk
Hypothyroidism	Endocrine disorders	MedDRA (25.0)	Systematic Assessment	EG00037 events30 affected255 at risk EG0011 events1 affected240 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00010 events9 affected255 at risk EG0019 events8 affected240 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00020 events17 affected255 at risk EG00127 events22 affected240 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00012 events9 affected255 at risk EG00118 events16 affected240 at risk
Constipation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00046 events41 affected255 at risk EG00160 events45 affected240 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00047 events32 affected255 at risk EG001134 events75 affected240 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00023 events22 affected255 at risk EG00122 events17 affected240 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00016 events14 affected255 at risk EG00113 events12 affected240 at risk
Nausea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00043 events37 affected255 at risk EG001123 events72 affected240 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00010 events9 affected255 at risk EG00121 events14 affected240 at risk
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG00033 events27 affected255 at risk EG00188 events48 affected240 at risk
Asthenia	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG00041 events29 affected255 at risk EG00163 events36 affected240 at risk
Fatigue	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG00043 events33 affected255 at risk EG00168 events42 affected240 at risk
Malaise	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG00018 events16 affected255 at risk EG00154 events35 affected240 at risk
Oedema peripheral	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG00012 events9 affected255 at risk EG00113 events11 affected240 at risk
Pyrexia	General disorders	MedDRA (25.0)	Non-systematic Assessment	EG00056 events40 affected255 at risk EG00142 events33 affected240 at risk
Nasopharyngitis	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG00014 events9 affected255 at risk EG0017 events6 affected240 at risk
Pneumonia	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG00031 events28 affected255 at risk EG00117 events14 affected240 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (25.0)	Non-systematic Assessment	EG00011 events8 affected255 at risk EG00111 events11 affected240 at risk
Alanine aminotransferase increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00049 events33 affected255 at risk EG00122 events19 affected240 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00055 events37 affected255 at risk EG00113 events11 affected240 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00026 events17 affected255 at risk EG00110 events5 affected240 at risk
Blood bilirubin increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00016 events9 affected255 at risk EG00111 events6 affected240 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00014 events11 affected255 at risk EG0011 events1 affected240 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00015 events10 affected255 at risk EG0010 events0 affected240 at risk
C-reactive protein increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG0008 events8 affected255 at risk EG0012 events2 affected240 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00023 events14 affected255 at risk EG00110 events8 affected240 at risk
Lymphocyte count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00021 events12 affected255 at risk EG00136 events22 affected240 at risk
Neutrophil count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00019 events6 affected255 at risk EG001202 events88 affected240 at risk
Platelet count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00023 events14 affected255 at risk EG00120 events16 affected240 at risk
Weight decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG000101 events62 affected255 at risk EG00155 events45 affected240 at risk
White blood cell count decreased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00025 events11 affected255 at risk EG001227 events95 affected240 at risk
White blood cell count increased	Investigations	MedDRA (25.0)	Non-systematic Assessment	EG00017 events12 affected255 at risk EG0018 events6 affected240 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00053 events42 affected255 at risk EG001102 events80 affected240 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00035 events17 affected255 at risk EG0018 events8 affected240 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00013 events8 affected255 at risk EG0013 events2 affected240 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00013 events6 affected255 at risk EG00119 events11 affected240 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00051 events36 affected255 at risk EG00144 events30 affected240 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00011 events8 affected255 at risk EG00117 events11 affected240 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00010 events6 affected255 at risk EG00113 events10 affected240 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00011 events8 affected255 at risk EG0014 events3 affected240 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00023 events22 affected255 at risk EG00142 events22 affected240 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00056 events31 affected255 at risk EG00145 events33 affected240 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Non-systematic Assessment	EG00014 events13 affected255 at risk EG00110 events8 affected240 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG00025 events22 affected255 at risk EG00124 events18 affected240 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG00032 events28 affected255 at risk EG00127 events17 affected240 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0009 events8 affected255 at risk EG00126 events14 affected240 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG00012 events10 affected255 at risk EG0014 events3 affected240 at risk
Dizziness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG00013 events11 affected255 at risk EG00126 events19 affected240 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0003 events2 affected255 at risk EG00136 events23 affected240 at risk
Insomnia	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG00024 events21 affected255 at risk EG00123 events17 affected240 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00056 events44 affected255 at risk EG00130 events28 affected240 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0008 events8 affected255 at risk EG0012 events2 affected240 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00029 events25 affected255 at risk EG00123 events19 affected240 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00011 events10 affected255 at risk EG0017 events5 affected240 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00012 events10 affected255 at risk EG0012 events2 affected240 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00021 events18 affected255 at risk EG00119 events18 affected240 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 events1 affected255 at risk EG00146 events42 affected240 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG00034 events25 affected255 at risk EG00113 events11 affected240 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG00031 events23 affected255 at risk EG00110 events10 affected240 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG00032 events13 affected255 at risk EG00115 events6 affected240 at risk
Hypotension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG00014 events10 affected255 at risk EG0018 events6 affected240 at risk

Certain Agreements

Ancestor Terms

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
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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	Term
D000077277	Esophageal Squamous Cell Carcinoma
D009362	Neoplasm Metastasis

ID	Term
C000707970	tislelizumab
D017239	Paclitaxel
D000077143	Docetaxel
D000077146	Irinotecan