Surufatinib in Combination With Tislelizumab in Subjects... | NCT04579757 | Trialant
NCT04579757
Sponsor
Hutchmed
Status
Terminated
Last Update Posted
May 8, 2025Actual
Enrollment
87Actual
Phase
Phase 1Phase 2
Conditions
Metastatic Solid Tumor
Colorectal Cancer
Neuroendocrine Tumors
Small Cell Lung Cancer
Gastric Cancer
Soft Tissue Sarcoma
Anaplastic Thyroid Cancer
Interventions
Surufatinib and Tislelizumab _ Part 1
Surufatinib and Tislelizumab _ Part 2
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04579757
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2020-012-GLOB1
Secondary IDs
Not provided
Brief Title
Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Official Title
An Open-Label Phase Ib/II Study of Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
HutchmedINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated by sponsor
Expanded Access Info
No
Start Date
Mar 5, 2021Actual
Primary Completion Date
Apr 30, 2024Actual
Completion Date
Aug 27, 2024Actual
First Submitted Date
Sep 2, 2020
First Submission Date that Met QC Criteria
Oct 4, 2020
First Posted Date
Oct 8, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 8, 2025
Results First Submitted that Met QC Criteria
May 7, 2025
Results First Posted Date
May 8, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 7, 2025
Last Update Posted Date
May 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
HutchmedINDUSTRY
Collaborators
Name
Class
BeiGene
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).
Detailed Description
This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).
Part 1 will be conducted to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of surufatinib in combination with tislelizumab in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to standard therapies.
Part 2 will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib in combination with tislelizumab in patients with specific types of advanced or metastatic solid tumors. Patients will receive the RP2D determined in part 1 of this study.
Conditions Module
Conditions
Metastatic Solid Tumor
Colorectal Cancer
Neuroendocrine Tumors
Small Cell Lung Cancer
Gastric Cancer
Soft Tissue Sarcoma
Anaplastic Thyroid Cancer
Keywords
VEGF
PD-1
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
87Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Surufatinib and tislelizumab (dose escalation_Part 1)
Experimental
In Part 1 (dose escalation), surufatinib and will be administered orally (PO) once daily (QD) and tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).
Drug: Surufatinib and Tislelizumab _ Part 1
Surufatinib and tislelizumab (indication specific_Part 2)
Experimental
In Part 2, the indication-specific expansion portion of the study, patients will receive surufatinib at the Recommended Phase 2 Dose (RP2D) dose selected in Part 1 with 200 mg tislelizumab IV, Q3W
Drug: Surufatinib and Tislelizumab _ Part 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Surufatinib and Tislelizumab _ Part 1
Drug
Part 1 (all cohorts): oral surufatinib at a dose based on cohort level and intravenous tislelizumab at a 200-mg dose
Surufatinib and tislelizumab (dose escalation_Part 1)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) version (v)5.0,DLT was defined as any of the following AEs during DLT observation period:
Nonhematologic toxicities:grade 3 or higher nonhematologic toxicity, except for grade 3 fatigue lasting <7 days, grade 3 rash returning to baseline or ≤grade 1 within 7 days with treatment, grade 3 hypertension downgraded to ≤grade 1 within 7 days with therapy, grade 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolving to ≤grade 1 within 7 days, grade 3 or higher amylase or lipase elevation without symptoms of pancreatitis, grade 3 nausea/vomiting or diarrhea for <72 hours with care, grade 3 or higher electrolyte abnormality lasting up to 72 hours and resolving with treatment. Hematologic toxicities: grade 3 or higher febrile neutropenia, grade 4 neutropenia and grade 4 thrombocytopenia lasting >7 days, grade 3 thrombocytopenia with severe bleeding, and grade 4 anemia.
From the first dose of study drug (Day 1) up to Day 21 of Cycle 1 (cycle duration: 3 weeks)
Dose Escalation Phase: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months
ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide informed consent
≥18 years of age
Part 1-have evaluable lesions (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1])
Part 2-have measurable lesions (according to RECIST v1.1)
Have a performance status of 0 or 1 on the ECOG scale
For female subjects of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly effective form(s) of contraception
Dose Escalation:
Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type,.
Dose Expansion:
Histologically or cytologically documented, locally advanced or metastatic:
Cohort A: adenocarcinoma of the colon or rectum that is microsatellite stable. Subjects must have progressed on, or had intolerable toxicity to, at least 3 prior regimens of standard chemotherapy.
Cohort B: progressive, low or intermediate grade (grade 1 or grade 2) NETs of thoracic or GEP origins. Subjects must have radiological documentation of progression of disease in the last 6 months and must have progressed on at least one line of standard therapy for metastatic disease.
Cohort C: SCLC that has progressed on standard first line chemotherapy treatment.
Cohort D: adenocarcinoma of the stomach or gastroesophageal junction and have progressed on at least 2 prior lines of therapy. Tumor stain for PD-L1 by Combined Positive Score (CPS) ≥5%.
Cohort E: ASPS or UPS. Subjects must have radiological documentation of disease progression in the last 3 months and have progressed on at least one line of standard therapy or refused standard frontline cytotoxic chemotherapy.
Cohort F: Anaplastic thyroid cancer that is considered not curable by resection. Patients with a BRAFV600E mutation must have previously been treated with 1 line of systemic therapy with a BRAF-targeted therapy.
Exclusion Criteria:
Adverse events (AEs) due to previous anti-tumor therapy has not recovered to Common Terminology Criteria for Adverse Event (CTCAE) ≤Grade 1;
Part 2 subjects with CRC , NETs and STS any previous treatment with anti-PD-1, anti PD-L1/L2 antibodies, anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody, or any other antibody acting on T cell costimulatory or checkpoint pathway;
Previous treatment with surufatinib;
Uncontrollable hypertension;
History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks) or life threatening thromboembolic event within 6 months;
Clinically significant cardiovascular disease;
Any clinically significant active infection, including, but not limited to, known human immunodeficiency virus (HIV) infection;
Brain metastases and/or leptomeningeal disease and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; subjects requiring steroids within 4 weeks prior to start of study treatment will be excluded;
Active autoimmune diseases or history of autoimmune diseases that may relapse with the following exceptions:
Controlled Type 1 diabetes
Hypothyroidism (provided it is managed with hormone-replacement therapy only)
Controlled celiac disease
Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
Any other disease that is not expected to recur in the absence of external triggering factors.
Arterial thrombosis or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months prior to first dosing;
History of deep venous thrombosis within 6 months;
Female patients who are pregnant or breastfeeding;
Any condition by which investigators judge patients not suitable to participate in this study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
William Schelman, MD
Hutchmed
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arizona Oncology Associated, PC-HOPE
Tucson
Arizona
85711
United States
City of Hope
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of a dose-escalation phase and a dose-expansion phase. A total of 12 patients in dose-escalation phase and 75 patients in dose-expansion phase were enrolled in this study. The study was terminated early based on the strategic re-evaluation of clinical development of surufatinib in the United States and Europe with no safety concerns. No patients were enrolled in Cohort E1 (alveolar soft part sarcoma) in the dose-expansion phase, hence this cohort is not presented in results.
Recruitment Details
This phase 1b/2, 2-part, open-label study was conducted in patients with advanced solid tumors.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 milligrams (mg) orally once daily (QD) in combination with tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) until progressive disease (PD), unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 29, 2023
Apr 2, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
HMPL-012, sulfatinib, BGB-A317
Surufatinib and Tislelizumab _ Part 2
Drug
Part 2 (all cohorts): oral surufatinib at the RP2D dose selected in Part 1 and intravenous tislelizumab at a 200-mg dose
Surufatinib and tislelizumab (indication specific_Part 2)
HMPL-012, sulfatinib, BGB-A317
ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 37 months
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Dose Escalation and Dose Expansion Phases: Progression-free Survival (PFS)
PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Dose Escalation and Dose Expansion Phases: Disease Control Rate (DCR)
DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Dose Escalation and Dose Expansion Phases: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Dose Escalation and Dose Expansion Phases: Duration of Response (DoR)
DoR was defined as the time from the first occurrence of PR or CR by RECIST v1.1, until PD or death, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Dose Escalation and Dose Expansion Phases: Time to Response (TTR)
TTR was defined as the time from start of study treatment until the date of first documented objective response, either CR or PR (whichever status was recorded first), according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Dose Escalation and Dose Expansion Phases: Plasma Concentration of Surufatinib
Blood samples were collected at the specified timepoints to determine plasma concentration of surufatinib.
Pre-dose on Day 1 of Cycles 1, 2, 5, 9, 17 and on Days 8 and 15 of Cycle 1; 2 to 4 hours post-dose on Days 1 and 15 of Cycle 1 (cycle duration: 3 weeks)
Dose Escalation and Dose Expansion Phases: Serum Concentration of Tislelizumab
Blood samples were collected at the specified timepoints to determine serum concentration of tislelizumab.
Preinfusion on Day 1 of Cycles 1, 2, 5, 9, 17; end of infusion on Day 1 of Cycles 1 and 5; on Days 8 and 15 of Cycle 1 (cycle duration: 3 weeks)
Dose Escalation and Dose Expansion Phases: Number of Patients With Antidrug Antibodies (ADA) to Tislelizumab
Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline.
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase
Dose Expansion Phase (Cohorts A and F): Overall Survival (OS)
OS was defined as the time from the start of study treatment until the date of death due to any cause.
From the first dose of study treatment (Day 1) up to date of death due to any cause, up to approximately 42 months
Dose Expansion Phase: Number of Patients With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events and TEAEs Leading to Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 33 months
Duarte
California
91010
United States
Rocky Mountain Cancer Centers Midtown
Denver
Colorado
80218
United States
Johns Hopkins University - Sibley Memorial Hospital
Washington D.C.
District of Columbia
20016
United States
Emory University - Winship Cancer Institute
Atlanta
Georgia
30322
United States
Holden Comprehensive Cancer Center, University of Iowa
Iowa City
Iowa
52242
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10021
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia
Pennsylvania
19104
United States
Prisma Health - Upstate (ITOR)
Greenville
South Carolina
29605
United States
Sarah Cannon
Nashville
Tennessee
37203
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Mary Crowley Cancer Research
Dallas
Texas
75230
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic colorectal cancer (CRC) that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic neuroendocrine tumor (NET) who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with gastroenteropancreatic (GEP) NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic small-cell lung cancer (SCLC) that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, programmed death-ligand 1 (PD-L1) ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (gastric cancer [GC]), and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG007
Dose Expansion Phase: Cohort E2: UPS
Patients with undifferentiated pleomorphic sarcoma (UPS) who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) and who had a B-Raf kinase V600E (BRAFV600E) mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
FG0006 subjects
FG0016 subjects
FG00215 subjects
FG00310 subjects
FG00420 subjects
FG00515 subjects
FG0063 subjects
FG0079 subjects
FG0083 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG00215 subjects
FG00310 subjects
FG00419 subjects
FG00515 subjects
FG0063 subjects
FG0078 subjects
FG0083 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Death
FG0004 subjects
FG0011 subjects
FG00214 subjects
FG0033 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Study Terminated By Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Radiological or Clinical PD
FG0001 subjects
FG0014 subjects
FG0021 subjects
FG0033 subjects
FG004
Start of New Therapy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety analysis set (SAS) included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG00215
BG00310
BG00420
BG00515
BG0063
BG0079
BG0083
BG00987
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
BG00062.5± 14.69
BG00168.2± 9.83
BG00253.5± 11.99
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Dose Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) version (v)5.0,DLT was defined as any of the following AEs during DLT observation period:
Nonhematologic toxicities:grade 3 or higher nonhematologic toxicity, except for grade 3 fatigue lasting <7 days, grade 3 rash returning to baseline or ≤grade 1 within 7 days with treatment, grade 3 hypertension downgraded to ≤grade 1 within 7 days with therapy, grade 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolving to ≤grade 1 within 7 days, grade 3 or higher amylase or lipase elevation without symptoms of pancreatitis, grade 3 nausea/vomiting or diarrhea for <72 hours with care, grade 3 or higher electrolyte abnormality lasting up to 72 hours and resolving with treatment. Hematologic toxicities: grade 3 or higher febrile neutropenia, grade 4 neutropenia and grade 4 thrombocytopenia lasting >7 days, grade 3 thrombocytopenia with severe bleeding, and grade 4 anemia.
The DLT-evaluable analysis set included all patients enrolled in dose escalation phase of the study who were evaluable for DLT assessment and received ≥85% of scheduled surufatinib and ≥67% of scheduled tislelizumab administration during the DLT assessment window and/or experienced a DLT.
Posted
Count of Participants
Participants
No
From the first dose of study drug (Day 1) up to Day 21 of Cycle 1 (cycle duration: 3 weeks)
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
Primary
Dose Escalation Phase: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Count of Participants
Participants
No
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 37 months
ID
Title
Description
OG000
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG001
Dose Expansion Phase: Cohort B1: Thoracic NETs
Secondary
Dose Escalation Phase: Objective Response Rate
ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Escalation and Dose Expansion Phases: Progression-free Survival (PFS)
PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Disease Control Rate (DCR)
DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Duration of Response (DoR)
DoR was defined as the time from the first occurrence of PR or CR by RECIST v1.1, until PD or death, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab. Only those patients with PR or CR (responders) were included in the analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Time to Response (TTR)
TTR was defined as the time from start of study treatment until the date of first documented objective response, either CR or PR (whichever status was recorded first), according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab. Only those patients with PR or CR (responders) were included in the analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Plasma Concentration of Surufatinib
Blood samples were collected at the specified timepoints to determine plasma concentration of surufatinib.
The pharmacokinetic (PK) analysis set included all patients with at least 1 quantifiable concentration of surufatinib or tislelizumab. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Pre-dose on Day 1 of Cycles 1, 2, 5, 9, 17 and on Days 8 and 15 of Cycle 1; 2 to 4 hours post-dose on Days 1 and 15 of Cycle 1 (cycle duration: 3 weeks)
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Serum Concentration of Tislelizumab
Blood samples were collected at the specified timepoints to determine serum concentration of tislelizumab.
The PK analysis set included all patients with at least 1 quantifiable concentration of surufatinib or tislelizumab. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Preinfusion on Day 1 of Cycles 1, 2, 5, 9, 17; end of infusion on Day 1 of Cycles 1 and 5; on Days 8 and 15 of Cycle 1 (cycle duration: 3 weeks)
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Escalation and Dose Expansion Phases: Number of Patients With Antidrug Antibodies (ADA) to Tislelizumab
Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline.
The ADA analysis set included all patients who received at least 1 dose of tislelizumab and had a baseline and at least 1 post-baseline ADA result.
Posted
Count of Participants
Participants
No
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Expansion Phase (Cohorts A and F): Overall Survival (OS)
OS was defined as the time from the start of study treatment until the date of death due to any cause.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab. As pre-specified in the protocol and statistical analysis plan (SAP), OS was assessed only in Cohort A (CRC) and Cohort F (ATC) of the dose expansion phase.
Posted
Median
95% Confidence Interval
months
From the first dose of study treatment (Day 1) up to date of death due to any cause, up to approximately 42 months
ID
Title
Description
OG000
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG001
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Secondary
Dose Expansion Phase: Number of Patients With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events and TEAEs Leading to Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Posted
Count of Participants
Participants
No
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 33 months
ID
Title
Description
OG000
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Time Frame
Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
Description
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
1
6
3
6
6
6
EG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
14
15
9
15
14
15
EG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
4
10
5
10
10
10
EG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
2
20
9
20
20
20
EG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
8
15
8
15
15
15
EG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
0
3
0
3
3
3
EG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
1
9
4
9
8
9
EG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
3
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Pancreatic fistula
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Disease progression
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hypertensive encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Biliary dyskinesia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Splenic rupture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Liver function test increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected6 at risk
EG0013 events3 affected6 at risk
EG00218 events10 affected15 at risk
EG00310 events5 affected10 at risk
EG00417 events12 affected20 at risk
EG00512 events6 affected15 at risk
EG0064 events3 affected3 at risk
EG0077 events4 affected9 at risk
EG0080 events0 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events3 affected6 at risk
EG00214 events6 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG00213 events7 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0024 events3 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0024 events2 affected15 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0024 events3 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected6 at risk
EG0015 events3 affected6 at risk
EG0029 events6 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Localised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Catheter site haematoma
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Facial pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Injection site pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Medical device site pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Xerosis
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected6 at risk
EG0029 events9 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0028 events5 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0024 events4 affected15 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0024 events4 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0024 events2 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected15 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0027 events4 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected6 at risk
EG0027 events5 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events4 affected6 at risk
EG0025 events4 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0025 events3 affected15 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0025 events4 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Blood creatine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Troponin T increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
White blood cell count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected6 at risk
EG00223 events10 affected15 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected15 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected15 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0026 events4 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Eye infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0024 events4 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Immune-mediated dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0016 events2 affected6 at risk
EG00213 events5 affected15 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Micturition disorder
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected6 at risk
EG0013 events1 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected15 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Incision site discharge
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected15 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Hepatic artery thrombosis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected15 at risk
EG003
Device occlusion
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected15 at risk
EG003
The study was terminated based on the strategic re-evaluation of the clinical development of surufatinib in the United States and Europe with no safety concerns.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG0006
OG0016
Any TESAEs
Title
Measurements
OG0005
OG0013
Any TEAEs leading to surufatinib treatment discontinuation
Title
Measurements
OG0003
OG0010
Any TEAEs leading to tislelizumab treatment discontinuation
Title
Measurements
OG0003
OG0010
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG002
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG00015
OG00110
OG00220
OG00315
OG0043
OG0059
OG0063
Title
Denominators
Categories
Title
Measurements
OG0006.7(0.2 to 31.9)
OG0010(NA to NA)NA indicates that upper and lower limits of confidence interval (CI) were not estimable as there were no patients with CR or PR in that disease cohort.
OG00215.0(3.2 to 37.9)
OG00313.3(1.7 to 40.5)
OG00433.3(0.8 to 90.6)
OG00544.4(13.7 to 78.8)
OG0060(NA to NA)NA indicates that upper and lower limits of CI were not estimable as there were no patients with CR or PR in that disease cohort.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limits of CI were not estimable as there were no patients with CR or PR in that disease cohort.
OG0010(NA to NA)NA indicates that upper and lower limits of CI were not estimable as there were no patients with CR or PR in that disease cohort.
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
OG00215
OG00310
OG00420
OG00515
OG0063
OG0079
OG0083
Title
Denominators
Categories
Title
Measurements
OG0001.5(1.2 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0016.0(1.8 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0024.7(2.7 to 5.4)
OG0034.5(0.3 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0047.4(3.1 to 20.0)
OG0051.4(1.0 to 4.0)
OG0069.6(5.6 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG007NA(1.3 to NA)NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
OG0082.8(1.2 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
OG00215
OG00310
OG00420
OG00515
OG0063
OG0079
OG0083
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD for at least 7 weeks.
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
OG00215
OG00310
OG00420
OG00515
OG0063
OG0079
OG0083
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
OG00150.0(11.8 to 88.2)
OG00220.0(4.3 to 48.1)
OG00320.0(2.5 to 55.6)
OG00440.0(19.1 to 63.9)
OG00513.3(1.7 to 40.5)
OG00633.3(0.8 to 90.6)
OG00744.4(13.7 to 78.8)
OG0080(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
OG0043
OG0052
OG0061
OG0074
OG0080
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
OG004NA(15.0 to NA)NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
OG0058.3(5.8 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG00611.0(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
OG007NA(NA to NA)NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
OG0043
OG0052
OG0061
OG0074
OG0080
Title
Denominators
Categories
Title
Measurements
OG0022.7(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
OG0043.9(2.7 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0053.5(1.3 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0062.7(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
OG0071.4(1.2 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
OG00215
OG00310
OG00419
OG00515
OG0063
OG0079
OG0082
Title
Denominators
Categories
Cycle 1 Day 1: Pre-dose
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00215
ParticipantsOG00310
ParticipantsOG00419
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0079
ParticipantsOG0082
Title
Measurements
OG000NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG001NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG002NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG003
Cycle 1 Day 1: 2 to 4 hours post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00215
ParticipantsOG00310
Cycle 1 Day 8: Pre-dose
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG00212
ParticipantsOG0035
Cycle 1 Day 15: Pre-dose
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG00211
ParticipantsOG0034
Cycle 1 Day 15: 2 to 4 hours post-dose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00213
ParticipantsOG0034
Cycle 2 Day 1: Pre-dose
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG0033
Cycle 5 Day 1: Pre-dose
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0031
Cycle 9 Day 1: Pre-dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Cycle 17 Day 1: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0016
OG00215
OG00310
OG00419
OG00515
OG0063
OG0079
OG0082
Title
Denominators
Categories
Cycle 1 Day 1: Preinfusion
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00215
ParticipantsOG0039
ParticipantsOG00419
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0079
ParticipantsOG0082
Title
Measurements
OG000NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG001NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG002NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG003
Cycle 1 Day 1: End of Infusion
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00215
ParticipantsOG00310
Cycle 1 Day 8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00213
ParticipantsOG0038
Cycle 1 Day 15
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00212
ParticipantsOG0037
Cycle 2 Day 1: Preinfusion
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG00214
ParticipantsOG0036
Cycle 5 Day 1: Preinfusion
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0031
Cycle 5 Day 1: End of Infusion
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0032
Cycle 9 Day 1: Preinfusion
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Cycle 17 Day 1: Preinfusion
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG002
Dose Expansion Phase: Cohort A: CRC
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG007
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG008
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG0006
OG0015
OG00214
OG0038
OG00416
OG00513
OG0062
OG0079
OG0082
Title
Denominators
Categories
Treatment-Boosted ADA
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Treatment-Induced ADA
Title
Measurements
OG0002
OG0012
OG0025
OG003
Units
Counts
Participants
OG00015
OG0013
Title
Denominators
Categories
Title
Measurements
OG0007.1(4.8 to 11.8)
OG0015.3(2.8 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG001
Dose Expansion Phase: Cohort B1: Thoracic NETs
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG002
Dose Expansion Phase: Cohort B2: GEP NETs
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG003
Dose Expansion Phase: Cohort C: SCLC
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG004
Dose Expansion Phase: Cohort D: GC
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG005
Dose Expansion Phase: Cohort E2: UPS
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
OG006
Dose Expansion Phase: Cohort F: ATC
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Units
Counts
Participants
OG00015
OG00110
OG00220
OG00315
OG0043
OG0059
OG0063
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG00014
OG00110
OG00220
OG00315
OG0043
OG0059
OG0063
Any TESAEs
Title
Measurements
OG0009
OG0015
OG0029
OG003
Any TEAEs leading to surufatinib treatment discontinuation
Title
Measurements
OG0003
OG0012
OG0025
OG003
Any TEAEs leading to tislelizumab treatment discontinuation
Title
Measurements
OG0006
OG0012
OG0026
OG003
1 events
1 affected
10 at risk
EG0042 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
2 events
1 affected
10 at risk
EG0041 events1 affected20 at risk
EG0052 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0042 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
2 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0041 events1 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0052 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
15 events
3 affected
10 at risk
EG00419 events11 affected20 at risk
EG0058 events6 affected15 at risk
EG0067 events3 affected3 at risk
EG00716 events4 affected9 at risk
EG0081 events1 affected3 at risk
4 events
3 affected
10 at risk
EG00410 events6 affected20 at risk
EG0056 events4 affected15 at risk
EG0060 events0 affected3 at risk
EG0075 events3 affected9 at risk
EG0080 events0 affected3 at risk
8 events
4 affected
10 at risk
EG0046 events4 affected20 at risk
EG0055 events5 affected15 at risk
EG0063 events2 affected3 at risk
EG0072 events2 affected9 at risk
EG0080 events0 affected3 at risk
2 events
2 affected
10 at risk
EG0042 events2 affected20 at risk
EG0053 events3 affected15 at risk
EG0061 events1 affected3 at risk
EG0073 events3 affected9 at risk
EG0082 events2 affected3 at risk
1 events
1 affected
10 at risk
EG0042 events2 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0044 events3 affected20 at risk
EG0051 events1 affected15 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
2 events
2 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0073 events2 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0043 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0043 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
11 events
5 affected
10 at risk
EG00414 events11 affected20 at risk
EG0058 events7 affected15 at risk
EG0064 events3 affected3 at risk
EG0076 events4 affected9 at risk
EG0082 events1 affected3 at risk
2 events
1 affected
10 at risk
EG00412 events7 affected20 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected3 at risk
EG0074 events3 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0052 events2 affected15 at risk
EG0060 events0 affected3 at risk
EG0074 events4 affected9 at risk
EG0080 events0 affected3 at risk
2 events
2 affected
10 at risk
EG0043 events3 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0073 events2 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0042 events1 affected20 at risk
EG0052 events2 affected15 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0043 events3 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0082 events2 affected3 at risk
1 events
1 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
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EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
2 events
2 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0042 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
5 events
4 affected
10 at risk
EG00447 events9 affected20 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected3 at risk
EG00710 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0045 events5 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
2 events
2 affected
10 at risk
EG0042 events2 affected20 at risk
EG0055 events3 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
2 events
1 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
3 events
3 affected
10 at risk
EG00411 events4 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0043 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0042 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0043 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
3 events
2 affected
10 at risk
EG0043 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0042 events2 affected20 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0082 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0042 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0041 events1 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
2 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0042 events2 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected3 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected3 at risk
NA
± NA
NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG004NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG005NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG006NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG007NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG008NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
ParticipantsOG00419
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0079
ParticipantsOG0082
Title
Measurements
OG000293.03± 244.593
OG001576.00± 415.108
OG002426.62± 312.209
OG003276.36± 243.080
OG004294.13± 292.335
OG005406.97± 212.791
OG006506.27± 653.616
OG007275.64± 165.937
OG008782.50± 463.155
ParticipantsOG00414
ParticipantsOG0059
ParticipantsOG0062
ParticipantsOG0076
ParticipantsOG0081
Title
Measurements
OG00077.00± 44.023
OG001189.93± 113.750
OG002170.33± 131.533
OG003100.12± 71.600
OG00492.26± 63.901
OG005122.80± 70.875
OG006109.10± 18.243
OG00797.70± 40.471
OG008709.00± NANA indicates that SD was not estimable for 1 patient.
ParticipantsOG00415
ParticipantsOG00510
ParticipantsOG0062
ParticipantsOG0076
ParticipantsOG0080
Title
Measurements
OG00064.36± 15.246
OG001181.56± 125.156
OG002135.96± 83.673
OG003159.00± 139.802
OG00484.95± 70.121
OG00596.79± 43.933
OG006111.05± 19.728
OG007118.92± 75.457
ParticipantsOG00412
ParticipantsOG00511
ParticipantsOG0062
ParticipantsOG0077
ParticipantsOG0080
Title
Measurements
OG000318.67± 146.770
OG001757.33± 498.399
OG002657.54± 369.146
OG003354.25± 52.519
OG004471.78± 330.598
OG005425.75± 235.698
OG006188.00± 41.012
OG007518.00± 302.182
ParticipantsOG0049
ParticipantsOG00511
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0081
Title
Measurements
OG00045.82± 27.567
OG00196.80± 38.895
OG002151.44± 99.521
OG00389.37± 53.475
OG00475.94± 53.028
OG005117.68± 79.721
OG006146.50± 26.163
OG00771.95± 9.405
OG008147.00± NANA indicates that SD was not estimable for 1 patient.
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00155.25± 8.132
OG002141.20± 117.885
OG00341.00± NANA indicates that SD was not estimable for 1 patient.
OG00461.08± 22.279
OG005105.70± 54.164
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00165.90± NANA indicates that SD was not estimable for 1 patient.
OG00487.20± 14.964
OG00541.70± NANA indicates that SD was not estimable for 1 patient.
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00485.10± NANA indicates that SD was not estimable for 1 patient.
NA
± NA
NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG004NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG005NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG006NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG007NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
OG008NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
ParticipantsOG00419
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0079
ParticipantsOG0082
Title
Measurements
OG00044550.0± 7420.98
OG00162750.0± 17420.53
OG00257233.3± 8846.28
OG00370990.0± 41600.73
OG00461136.8± 15927.90
OG00566220.0± 17336.43
OG00667966.7± 45015.59
OG00755955.6± 15499.61
OG00842200.0± 12727.92
Participants
OG004
18
ParticipantsOG00512
ParticipantsOG0063
ParticipantsOG0078
ParticipantsOG0082
Title
Measurements
OG00016980.0± 6850.75
OG00126216.7± 7702.32
OG00226446.2± 6387.83
OG00329575.0± 5751.46
OG00432244.4± 7253.58
OG00535450.0± 8899.39
OG00638233.3± 35800.33
OG00725475.0± 6549.10
OG00816050.0± 1767.77
Participants
OG004
16
ParticipantsOG00512
ParticipantsOG0062
ParticipantsOG0078
ParticipantsOG0082
Title
Measurements
OG00014296.7± 5945.36
OG00117900.0± 5297.55
OG00217414.2± 4199.94
OG00320571.4± 2817.63
OG00424506.3± 6403.07
OG00523783.3± 4274.20
OG00643950.0± 40658.64
OG00719300.0± 4755.45
OG00810940.0± 2489.02
ParticipantsOG00415
ParticipantsOG00512
ParticipantsOG0062
ParticipantsOG0078
ParticipantsOG0082
Title
Measurements
OG0009564.0± 7871.14
OG00113804.0± 4782.16
OG00213858.6± 4730.49
OG00314033.3± 2436.12
OG00418020.0± 5688.23
OG00517725.0± 3860.55
OG00638000.0± 36910.97
OG00712161.3± 4443.93
OG0087640.0± 2729.43
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0081
Title
Measurements
OG00124400.0± 14028.90
OG00236412.5± 34947.57
OG00346400.0± NANA indicates that SD was not estimable for 1 patient.
OG00441575.0± 10065.32
OG00531225.0± 12388.81
OG00620100.0± NANA indicates that SD was not estimable for 1 patient.
OG00719200.0± 3143.25
OG00822700.0± NANA indicates that SD was not estimable for 1 patient.
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0081
Title
Measurements
OG00187166.7± 34425.04
OG002102500.0± 26662.02
OG003117500.0± 6363.96
OG004113475.0± 16286.34
OG005117550.0± 43800.65
OG00680800.0± NANA indicates that SD was not estimable for 1 patient.
OG007103033.3± 17737.06
OG00869000.0± NANA indicates that SD was not estimable for 1 patient.
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG00122700.0± 4101.22
OG00244800.0± NANA indicates that SD was not estimable for 1 patient.
OG00350000.0± NANA indicates that SD was not estimable for 1 patient.
OG00445500.0± 5384.24
OG00541200.0± 24607.32
OG00741100.0± 16970.56
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
Title
Measurements
OG00341300.0± NANA indicates that SD was not estimable for 1 patient.
OG00444766.7± 12196.86
OG00551900.0± NANA indicates that SD was not estimable for 1 patient.
OG00747300.0± NANA indicates that SD was not estimable for 1 patient.