Study of BGB-A317 in Participants With Relapsed or Refrac... | NCT03493451

ID	Type	Description	Link
2017-003700-44	EudraCT Number
CTR20171387	Registry Identifier	Center for drug evaluation, CFDA

Label	Type	Description	Intervention Names
Cohort 1: ENKTL	Experimental	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Drug: Tislelizumab
Cohort 2: PTCL-NOS, AITL, and ALCL	Experimental	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Drug: Tislelizumab
Cohort 3: MF and SS	Experimental	Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	Drug: Tislelizumab

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab	Drug	Administered intravenously	Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3.	Up to approximately 3 years and 1 week

Measure	Description	Time Frame
Duration of Response (DOR)	DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.	Up to approximately 3 years and 1 week

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
British Columbia Cancer Agency the Vancouver Centre		Vancouver	British Columbia	V5Z 4E6	Canada
Peking University Third Hospital

PubMed Identifier	Type	Citation
	Background	Huiqiang Huang, et al. Tislelizumab (BGB-A317) for relapsed/refractory extranodal NK/T-cell lymphoma: preliminary efficacy and safety results from a phase 2 study. Poster Abstract EP1268, European Hematology Association 2020.
	Background	Pier Luigi Zinzani, et al. Tislelizumab (BGB-A317) for relapsed/refractory peripheral T-cell lymphomas: Safety and efficacy results from a phase 2 study. Poster Abstract EP1235, European Hematology Association 2020.
37276067	Derived	Bachy E, Savage KJ, Huang H, Kwong YL, Gritti G, Zhang Q, Liberati AM, Cao J, Yang H, Hao S, Hu J, Zhou K, Petrini M, Russo F, Zhang H, Sang W, Ji J, Ferreri AJM, Damaj GL, Liu H, Zhang W, Ke X, Ghiggi C, Huang S, Li X, Yao H, Paik J, Novotny W, Zhou W, Zhu H, Zinzani PL. Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study. Blood Adv. 2023 Aug 22;7(16):4435-4447. doi: 10.1182/bloodadvances.2022009575.

ID	Title	Description
FG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 14, 2019	Mar 25, 2022

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 Response Rate (ORR)

ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3.

Safety analysis set includes all participants who received at least one dose of study drug

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG002	Cohort 3: MF and SS	Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Units	Counts
Participants	OG00022 OG00144 OG00211

Title

Denominators

Categories

Title	Measurements
	OG00031.8(13.9 to 54.9) OG00120.5(9.8 to 35.3) OG00245.5(16.7 to 76.6)

Secondary

Duration of Response (DOR)

DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Safety analysis set includes all participants who received at least one dose of study drug; Duration of response was summarized for responders (participants who achieved a partial or complete response).

Posted

Median

95% Confidence Interval

Months

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Secondary

Progression-free Survival (PFS)

PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Safety analysis set includes all participants who received at least one dose of study drug

Posted

Median

95% Confidence Interval

Months

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG002

Secondary

Overall Survival (OS)

OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.

Safety analysis set includes all participants who received at least one dose of study drug

Posted

Median

95% Confidence Interval

Months

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Units	Counts

Secondary

Complete Response Rate (CRR)

CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Safety analysis set includes all participants who received at least one dose of study drug

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG002

Secondary

Time to Response (TTR)

Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Safety analysis set includes all participants who received at least one dose of study drug; Time to response was summarized for responders (participants who achieved a partial or complete response).

Posted

Median

Full Range

Months

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Secondary

Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score

Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue 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.' An increasing score indicates improvements from baseline.

Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Posted

Mean

Standard Deviation

Score on a scale

Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Secondary

Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score

Mean change from baseline at safety follow-up visit 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 cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Posted

Mean

Standard Deviation

Score on a scale

Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Secondary

Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score

Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Posted

Mean

Standard Deviation

Score on a scale

Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Secondary

Number of Participants With Adverse Events

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs

Safety analysis set includes all participants who received at least one dose of study drug

Posted

Count of Participants

Participants

Up to approximately 3 years and 1 week

ID	Title	Description
OG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
OG002	Cohort 3: MF and SS

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events2 affected44 at risk EG0020 events0 affected11 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Vision blurred	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Intussusception	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
General physical health deterioration	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events1 affected44 at risk EG0020 events0 affected11 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0018 events4 affected44 at risk EG0020 events0 affected11 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Oral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events2 affected22 at risk EG0014 events4 affected44 at risk EG0020 events0 affected11 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected44 at risk EG0020 events0 affected11 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Tonsillitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Epstein-Barr virus test positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Renal impairment	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0022 events1 affected11 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events1 affected44 at risk EG0020 events0 affected11 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00014 events6 affected22 at risk EG0018 events7 affected44 at risk EG0020 events0 affected11 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events2 affected44 at risk EG0020 events0 affected11 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events2 affected44 at risk EG0020 events0 affected11 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG00113 events5 affected44 at risk EG0020 events0 affected11 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG00111 events7 affected44 at risk EG0020 events0 affected11 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Conduction disorder	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Extrasystoles	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Palpitations	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Deafness	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected44 at risk EG0020 events0 affected11 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0015 events5 affected44 at risk EG0024 events3 affected11 at risk
Blepharitis	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Eversion of lacrimal punctum	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Eyelid oedema	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Lacrimation increased	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Periorbital oedema	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Retinal disorder	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Retinopathy	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0012 events2 affected44 at risk EG0022 events2 affected11 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events1 affected44 at risk EG0020 events0 affected11 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events4 affected44 at risk EG0022 events2 affected11 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0014 events4 affected44 at risk EG0025 events4 affected11 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events3 affected44 at risk EG0020 events0 affected11 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0011 events1 affected44 at risk EG0022 events2 affected11 at risk
Oral cavity fistula	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0011 events1 affected44 at risk EG0022 events2 affected11 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected44 at risk EG0023 events3 affected11 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0019 events8 affected44 at risk EG0022 events2 affected11 at risk
Chest discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Face oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected44 at risk EG0022 events1 affected11 at risk
Influenza like illness	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected44 at risk EG0023 events3 affected11 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0013 events3 affected44 at risk EG0026 events4 affected11 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00013 events6 affected22 at risk EG00125 events13 affected44 at risk EG0027 events4 affected11 at risk
Swelling face	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Gingivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Herpes simplex	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Impetigo	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0013 events2 affected44 at risk EG0021 events1 affected11 at risk
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Pseudomonal skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Skin bacterial infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0018 events5 affected44 at risk EG0020 events0 affected11 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Wound infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0015 events3 affected44 at risk EG0020 events0 affected11 at risk
Alpha hydroxybutyrate dehydrogenase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected44 at risk EG0020 events0 affected11 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected22 at risk EG0013 events3 affected44 at risk EG0020 events0 affected11 at risk
Blood albumin decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected44 at risk EG0020 events0 affected11 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 events2 affected22 at risk EG0012 events1 affected44 at risk EG0020 events0 affected11 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 events2 affected22 at risk EG0011 events1 affected44 at risk EG0024 events1 affected11 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0016 events3 affected44 at risk EG0021 events1 affected11 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0017 events4 affected44 at risk EG0020 events0 affected11 at risk
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
C-reactive protein increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Haemoglobin decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Lymphocyte count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0009 events3 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00016 events4 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00010 events2 affected22 at risk EG0015 events4 affected44 at risk EG0020 events0 affected11 at risk
Tri-iodothyronine free decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0008 events4 affected22 at risk EG0015 events4 affected44 at risk EG0020 events0 affected11 at risk
Weight increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00011 events3 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
White blood cell count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00021 events4 affected22 at risk EG0016 events3 affected44 at risk EG0020 events0 affected11 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected22 at risk EG0015 events4 affected44 at risk EG0021 events1 affected11 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0008 events5 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected22 at risk EG0013 events2 affected44 at risk EG0020 events0 affected11 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0007 events3 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events3 affected22 at risk EG00118 events7 affected44 at risk EG0025 events3 affected11 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0024 events1 affected11 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected44 at risk EG0021 events1 affected11 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events3 affected44 at risk EG0020 events0 affected11 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Delirium	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events4 affected44 at risk EG0021 events1 affected11 at risk
Renal impairment	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected22 at risk EG00110 events7 affected44 at risk EG0020 events0 affected11 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected44 at risk EG0021 events1 affected11 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected44 at risk EG0020 events0 affected11 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Circumoral oedema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0022 events1 affected11 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0020 events0 affected11 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG00110 events5 affected44 at risk EG0021 events1 affected11 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0019 events6 affected44 at risk EG0024 events3 affected11 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected44 at risk EG0024 events3 affected11 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0011 events1 affected44 at risk EG0020 events0 affected11 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0018 events2 affected44 at risk EG0020 events0 affected11 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0020 events0 affected11 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected44 at risk EG0023 events1 affected11 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected44 at risk EG0021 events1 affected11 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected44 at risk EG0021 events1 affected11 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected44 at risk EG0022 events2 affected11 at risk

ID	Term
D016411	Lymphoma, T-Cell, Peripheral
D054391	Lymphoma, Extranodal NK-T-Cell
D007119	Immunoblastic Lymphadenopathy
D016399	Lymphoma, T-Cell
D017728	Lymphoma, Large-Cell, Anaplastic
D016410	Lymphoma, T-Cell, Cutaneous
D012008	Recurrence

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D000072281	Lymphadenopathy
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
BG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
BG002	Cohort 3: MF and SS	Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: ENKTL	Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	11	22	9	22	21	22
EG001	Cohort 2: PTCL-NOS, AITL, and ALCL	Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	26	44	21	44	39	44
EG002	Cohort 3: MF and SS	Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)	3	11	5	11	10	11