A Multi-Center, Open-Label Study of Fruquintinib in Solid... | NCT03251378 | Trialant
NCT03251378
Sponsor
Hutchison Medipharma Limited
Status
Completed
Last Update Posted
Sep 25, 2024Actual
Enrollment
129Actual
Phase
Phase 1
Conditions
Advanced Solid Tumors
Metastatic Colon Cancer
Metastatic Breast Cancer
Triple Negative Breast Cancer
HER2-negative Breast Cancer
Hormone Receptor Positive Breast Carcinoma
Rectal Cancer
Interventions
Fruquintinib (HMPL-013)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03251378
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2015-013-00US1
Secondary IDs
Not provided
Brief Title
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
Official Title
A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
HutchmedINDUSTRY
Status Module
Record Verification Date
May 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 11, 2017Actual
Primary Completion Date
Dec 13, 2022Actual
Completion Date
Mar 30, 2023Actual
First Submitted Date
Jul 19, 2017
First Submission Date that Met QC Criteria
Aug 13, 2017
First Posted Date
Aug 16, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 6, 2023
Results First Submitted that Met QC Criteria
May 30, 2024
Results First Posted Date
Sep 25, 2024Actual
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 30, 2024
Last Update Posted Date
Sep 25, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hutchison Medipharma LimitedINDUSTRY
Collaborators
Not provided
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
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
Detailed Description
The study was an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study consisted of two phases:
A dose escalation phase - Two dose cohorts were evaluated including 3 mg orally QD 3 weeks on/1 week off and 5 mg orally QD 3 weeks on/1 week off. A 3+3 design was used for this portion of the study.
A dose expansion phase - Five cohorts were evaluated in Dose Expansion phase. Cohort A evaluated the MTD/RP2D in patients with advanced solid tumors of any type. Cohort B and Cohort C evaluated the MTD/RP2D in metastatic colorectal cancer patients. Cohort D and Cohort E evaluated the MTD/RP2D in metastatic breast cancer patients.
Study was conducted at 9 sites in the United States.
Conditions Module
Conditions
Advanced Solid Tumors
Metastatic Colon Cancer
Metastatic Breast Cancer
Triple Negative Breast Cancer
HER2-negative Breast Cancer
Hormone Receptor Positive Breast Carcinoma
Rectal Cancer
Keywords
VEGF
colorectal
breast
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
129Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
3 mg Dose Escalation
Experimental
3 mg of Fruquintinib (HMPL-013), capsule taken orally, daily, 3 weeks on, 1 week off
Drug: Fruquintinib (HMPL-013)
5 mg Dose Escalation
Experimental
5 mg of Fruquintinib (HMPL-013), capsule taken orally, daily, 3 weeks on, 1 week off
Drug: Fruquintinib (HMPL-013)
Fruquintinib Expansion Cohort A
Experimental
5 mg fruquintinib (HMPL-013) capsule taken orally, daily, 3 weeks on, 1 week off in patients with advanced solid tumors of any type.
Drug: Fruquintinib (HMPL-013)
Metastatic Colorectal Cancer Expansion Cohort B (prior trifluridine/tipiracil or regorafenib)
Experimental
5 mg fruquintinib (HMPL-013) capsule taken orally, daily, 3 weeks on, 1 week off in patients with metastatic colorectal cancer who have progressed on or had intolerable toxicity to TAS-102, regoragenib, or both.
Drug: Fruquintinib (HMPL-013)
Metastatic Colorectal Cancer Expansion Cohort C (no prior trifluridine/tipiracil or regorafenib)
Experimental
5 mg fruquintinib (HMPL-013) capsule taken orally, daily, 3 weeks on, 1 week off in patients with metastatic colorectal cancer who have not been treated with TAS-102 or regorafenib.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fruquintinib (HMPL-013)
Drug
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
Dose-limiting toxicity was defined as: Any Grade 4 non-hematologic toxicity; Any Grade 3 non-hematologic toxicity related to study drug except for nausea/vomiting, diarrhea, constipation, hypertension, and electrolyte imbalances downgraded within 3-days with appropriate supportive treatment; Grade 4 neutropenia lasting >3 days; Grade 3 febrile neutropenia (absolute neutrophil count [ANC] <1.0*10^9 per liter [/L] with a single temperature of greater than (>) 38.3 degree centigrade (°C) or a sustained temperature of greater than or equal to (>=) 38°C for more than 1 hour); Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with bleeding; Dose interruption for >14 days due to toxicity.
Cycle 1 (cycle length equal to [=] 28 days)
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study medication and no later than 37 days after the date of last study treatment. A serious adverse event (SAE) was any AE that had any of the following characteristics: Fatal (that was, the AE actually caused or led to death, except for deaths caused by the progress of disease); Life threatening (that was, AE, in view of the investigator, places participant at immediate risk of death); Required or prolonged inpatient hospitalization (excluding emergency or outpatient treatment); Resulted in persistent or significant disability/incapacity (that was, the AE resulted in substantial disruption of the participant's ability to conduct normal life functions).
From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months)
PFS was defined as time from date of first dosing until date of an objective disease progression (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or death due to any cause, whichever comes first. PFS was determined using all data until last evaluable visit prior to or on date of: (i) radiographic PD per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than study drugs, whichever was earlier. PFS rate was defined as probability of being disease progression free at selected timepoints such as 16 weeks and was calculated using Brookmeyer-Crowley method based on PFS events observed up to 29 months. PD:at least 20 percent (%) increase in sum of diameters of target lesions, taking as reference smallest sum on study, including baseline; an absolute increase of at least 5 millimeter (mm) in sum of diameters of target lesions; and appearance of one or more new lesions.
Secondary Outcomes
Measure
Description
Time Frame
Dose Escalation and Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Fruquintinib
Cmax of fruquintinib was reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Fully understand the study and voluntarily sign the ICF;
≥18years of age;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Dose Escalation Phase:
• Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type (except squamous NSCLC) that has progressed on approved systemic therapy, and for whom no effective therapy or standard of care exists. This cohort is closed to enrollment.
Dose Expansion Phase:
Cohort A: Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type (except squamous NSCLC), that has progressed on approved systemic therapy, and for whom no effective therapy or standard of care exists. This cohort is closed to enrollment.
Cohort B: Histologically or cytologically documented mCRC in patients that have progressed on, or had intolerable toxicity with at least 1 FDA-approved third-line systemic therapy (trifluridine/tipiracil or regorafenib). Patients must also have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and an anti-EGFR therapy for patients who had RAS wild-type tumors. This cohort is currently enrolling.
Cohort C: Histologically or cytologically documented adenocarcinoma of the colon or rectum. Patients must have progressed on, or had intolerable toxicity to, at least 2 prior regimens of standard chemotherapy, but must not have received prior TAS-102 or regorafenib. Prior therapy could have included adjuvant chemotherapy if a tumor had recurred within 6 months after the last administration of treatment. Patients must have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy
Cohort D only: Histologically- or cytologically-confirmed Her2-negative, hormone receptor positive (ER+ and/or PR+) breast cancer
Cohort E only: Histologically- or cytologically- confirmed triple negative breast cancer
Key Exclusion Criteria:
Patients will be excluded from the study, if any of the following criteria is met:
Severe anemia, neutropenia, thrombocytopenia
Moderate to severe renal or hepatic impairment
Uncontrolled hypertension
Risk of, or active hemorrhage: history or presence of active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation of fistulas; or any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation within 6 months prior to screening;
History of a thromboembolic event (including deep vein thrombosis [DVT], pulmonary embolism, stroke and/or transient ischemic attack) within 6 months prior to screening;
Patients with squamous NSCLC;
Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) <50%;
Patients who have ever received a VEGFR inhibitor, except for patients with mCRC enrolled in the dose expansion phase;
Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
Systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study drug;
Brachytherapy (ie, implantation of radioactive seeds) within 60 days prior to the first dose of study drug;
Known human immunodeficiency virus (HIV) infection;
Known clinically significant history of liver disease, including cirrhosis, current alcohol abuse or active viral hepatitis. For patients with evidence of chronic hepatitis B (HBV), the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV who are currently on treatment, they are eligible if they have an undetectable HCV viral load;
Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava.;
Women who are pregnant or lactating;
Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded;
No other malignancy, except for non-melanoma skin cancer, during the 5 years prior to screening;
Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment;
Known hypersensitivity to fruquintinib or any of its excipients.
For Cohort C only: patients who have been previously treated with TAS-102 or regorafenib
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
HUTCHMED International
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mayo Clinic Arizona
Phoenix
Arizona
85054
United States
California Cancer Care Associates for Research & Excellence, Inc.
Wang-Gillam A, Schelman W, Ukrainskyj S, Chien C, Gonzalez M, Yang Z, Kania M, Yeckes-Rodin H. Phase 1/1b open-label, dose-escalation study of fruquintinib in patients with advanced solid tumors in the United States. Invest New Drugs. 2023 Dec;41(6):851-860. doi: 10.1007/s10637-023-01395-y. Epub 2023 Oct 5.
See Also Links
Not provided
Available IPD Information
Not provided
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
A total of 129 participants (14 in Dose Escalation Phase and 115 in Dose Expansion Phase) were treated in this study.
Recruitment Details
The study was conducted at 9 study sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 milligram (mg) capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
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
Not provided
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
Jan 9, 2020
Nov 28, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
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
Drug: Fruquintinib (HMPL-013)
Metastatic Breast Cancer (HR positive, HER2 negative) Expansion Cohort D
Experimental
5 mg fruquintinib (HMPL-013) capsule taken orally, daily, 3 weeks on, 1 week off in patients with metastatic Her2-negative, hormone receptor positive breast cancer.
Drug: Fruquintinib (HMPL-013)
Metastatic Breast Cancer (TNBC) Expansion Cohort E
Experimental
5 mg fruquintinib (HMPL-013) capsule taken orally, daily, 3 weeks on, 1 week off in patients with metastatic triple negative (Her2-negative, ER-negative, PR-negative) breast cancer.
Drug: Fruquintinib (HMPL-013)
3 mg Dose Escalation
5 mg Dose Escalation
Fruquintinib Expansion Cohort A
Metastatic Breast Cancer (HR positive, HER2 negative) Expansion Cohort D
Metastatic Breast Cancer (TNBC) Expansion Cohort E
Metastatic Colorectal Cancer Expansion Cohort B (prior trifluridine/tipiracil or regorafenib)
Metastatic Colorectal Cancer Expansion Cohort C (no prior trifluridine/tipiracil or regorafenib)
HMPL-013
From the first dose of study drug to disease progression, or death, whichever occurred first (i.e., up to 29 months)
Dose Escalation and Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Fruquintinib
Tmax of fruquintinib over a dosing intervals were reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Minimum Observed Plasma Concentration (Cmin) of Fruquintinib
Cmin of fruquintinib was reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Time to Reach Minimum Observed Plasma Concentration (Tmin) of Fruquintinib
Tmin of fruquintinib was reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Fruquintinib
AUC0-24 of fruquintinib was reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Apparent Clearance at Steady State (CL/Fss) of Fruquintinib
CL/Fss was calculated as Dose/AUC0-t. As planned, CL/Fss was assessed at Cycle 1 Days 14 and 21 after multiple dose administration in Dose Escalation Phase and Cohort A of Dose Expansion Phase; and at Cycle 1 Day 14 for Cohort B, C, D, E of Expansion Phase.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Accumulation Ratio Based on Cmax of Fruquintinib
Accumulation ratio based on Cmax for Cycle 1 Day 14 was calculated as Day 14 Cmax /Day 1 Cmax and for Cycle 1 Day 21 was calculated as Day 21 Cmax /Day 1 Cmax. Accumulation ratio based on Cmax of fruquintinib was reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14 and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Accumulation Ratio Based on AUC0-24 Hours of Fruquintinib
Accumulation ratio for Cycle 1 Day 14 was calculated as AUC0-24 at Day 14 divided by AUC0-24h at Day 1, and for Cycle 1 Day 21 was calculated as AUC0-24 at Day 21 divided by AUC0-24 at Day 1. Accumulation ratio based on AUC0-24 of fruquintinib was reported.
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14 and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
Dose Escalation and Expansion Phase: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with objective complete response (CR) or partial response (PR) response per RECIST version 1.1. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
From the first dose of study drug until first documentation of best overall response (i.e., up to 29 months)
Dose Escalation and Expansion Phase: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, confirmed PR or stable disease (SD) (for 7 weeks) per RECIST version 1.1. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined 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 progressive disease (PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study [this might include the baseline sum]).
From the first dose of study drug until first documentation of best overall response (i.e., up to 29 months)
Dose Escalation and Expansion Phase: Duration of Response (DoR)
DoR was defined as the time (in months) from the date of the first objective response (CR or PR) until the date of the documented progression or of death, whichever comes first. DoR was only analyzed for participants whose best overall response (BOR) was either CR or PR. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 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 (this might include the baseline sum). DoR was calculated using the Kaplan-Meier method.
From the date of the first objective response (CR or PR) until the date of the documented disease progression or of death, whichever comes first (i.e., up to 29 months)
Dose Escalation and Expansion Phase: Progression Free Survival (PFS)
PFS was defined as the time (in months) from date of first dosing until the date of an objective disease progression as per RECIST version 1.1 or death due to any cause, whichever comes first. PFS was determined using all the assessment data up until the last evaluable visit prior to or on the date of (i) disease progression as defined by RECIST version 1.1 or death; or (ii) withdrawal of consent; or (iii) receiving subsequent anti-cancer therapy, whichever is earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this might include the baseline sum). PFS was calculated using the Kaplan-Meier method.
From date of first dose until the date of an objective disease progression or death due to any cause, whichever comes first (i.e., up to 29 months)
Dose Escalation and Expansion Phase: Overall Survival (OS)
OS was defined as the time interval (in months) between the first dose date and the date of death (any cause). OS was calculated using the Kaplan-Meier method.
From first dose date to the date of death (due to any cause) (i.e., up to 29 months)
Dose Escalation and Expansion Phase: Percent Change From Baseline (PCFB) in Tumor Size
Tumor size was estimated using data on sum of diameters of target lesion. Percentage change in tumor size from baseline was determined for participants with measurable disease at baseline and derived by the percentage change in the sum of the diameters of target lesions (TLs) compared to baseline. Baseline was defined as the last evaluable tumor assessment result obtained prior to the first administration of study medication.
Baseline up to 29 months
Dose Expansion Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study medication and no later than 37 days after the date of last study treatment. A SAE was any AE that had any of the following characteristics: Fatal (that was, the AE actually caused or led to death, except for deaths caused by the progress of disease); Life threatening (that was, AE, in view of the investigator, places participant at immediate risk of death); Required or prolonged inpatient hospitalization (excluding emergency or outpatient treatment); Resulted in persistent or significant disability/incapacity (that was, the AE resulted in substantial disruption of the participant's ability to conduct normal life functions).
From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months)
San Marcos
California
92069
United States
St. Joseph Heritage Healthcare
Santa Rosa
California
95403
United States
University of Colorado Cancer Center
Aurora
Colorado
80045
United States
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie
Florida
34952
United States
Mayo Clinic Rochester
Rochester
Minnesota
55902
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Vanderbilt Ingram Cancer Center
Nashville
Tennessee
37232
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
FG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
FG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
FG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with metastatic colorectal carcinoma (mCRC) and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
FG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
FG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC) received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
FG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with triple negative breast cancer (TNBC) received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
FG0007 subjects
FG0017 subjects
FG0026 subjects
FG00341 subjects
FG00440 subjects
FG00514 subjects
FG00614 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0007 subjects
FG0017 subjects
FG0026 subjects
FG00341 subjects
FG00440 subjects
FG00514 subjects
FG00614 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG00330 subjects
FG00424 subjects
FG00512 subjects
FG00612 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG004
Patient withdrew consent and refused to provide follow-up information
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
Progressive disease
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
The safety analysis set (SAS) included all participants who received at least 1 dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0017
BG0026
BG00341
BG00440
BG00514
BG00614
BG007129
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00061.08± 5.566
BG00157.72± 12.712
BG00268.91± 8.879
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
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 Participants With Dose-limiting Toxicities (DLTs)
Dose-limiting toxicity was defined as: Any Grade 4 non-hematologic toxicity; Any Grade 3 non-hematologic toxicity related to study drug except for nausea/vomiting, diarrhea, constipation, hypertension, and electrolyte imbalances downgraded within 3-days with appropriate supportive treatment; Grade 4 neutropenia lasting >3 days; Grade 3 febrile neutropenia (absolute neutrophil count [ANC] <1.0*10^9 per liter [/L] with a single temperature of greater than (>) 38.3 degree centigrade (°C) or a sustained temperature of greater than or equal to (>=) 38°C for more than 1 hour); Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with bleeding; Dose interruption for >14 days due to toxicity.
The DLT evaluable set comprised all participants who were evaluable for DLT assessment. As planned, this outcome measure (OM) was assessed in Dose Escalation Phase only.
Posted
Count of Participants
Participants
Cycle 1 (cycle length equal to [=] 28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
Primary
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study medication and no later than 37 days after the date of last study treatment. A serious adverse event (SAE) was any AE that had any of the following characteristics: Fatal (that was, the AE actually caused or led to death, except for deaths caused by the progress of disease); Life threatening (that was, AE, in view of the investigator, places participant at immediate risk of death); Required or prolonged inpatient hospitalization (excluding emergency or outpatient treatment); Resulted in persistent or significant disability/incapacity (that was, the AE resulted in substantial disruption of the participant's ability to conduct normal life functions).
The SAS included all participants who received at least 1 dose of the study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
PFS was defined as time from date of first dosing until date of an objective disease progression (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or death due to any cause, whichever comes first. PFS was determined using all data until last evaluable visit prior to or on date of: (i) radiographic PD per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than study drugs, whichever was earlier. PFS rate was defined as probability of being disease progression free at selected timepoints such as 16 weeks and was calculated using Brookmeyer-Crowley method based on PFS events observed up to 29 months. PD:at least 20 percent (%) increase in sum of diameters of target lesions, taking as reference smallest sum on study, including baseline; an absolute increase of at least 5 millimeter (mm) in sum of diameters of target lesions; and appearance of one or more new lesions.
The SAS included all participants who received at least 1 dose of the study drug.
Posted
Number
95% Confidence Interval
percentage of participants
From the first dose of study drug to disease progression, or death, whichever occurred first (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Fruquintinib
Cmax of fruquintinib was reported.
Pharmacokinetic (PK) evaluable population included all participants who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. Here, "number analyzed" signifies participants who were evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Days 1 and 14; and for the Dose Escalation Phase and Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Fruquintinib
Tmax of fruquintinib over a dosing intervals were reported.
PK evaluable population included all participants who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. Here, "number analyzed" signifies participants who were evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Days 1 and 14; and for the Dose Escalation Phase and Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Median
Full Range
hours
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Minimum Observed Plasma Concentration (Cmin) of Fruquintinib
Cmin of fruquintinib was reported.
PK evaluable population: all participants who received at least 1 dose of study drug and had a sufficient PK profile to derive at least 1 PK parameter. "Overall number of participants analyzed" signifies participants evaluable for this OM; "number analyzed" signifies participants evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Day 14; and for Dose Escalation Phase and Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Mean
Standard Deviation
ng/mL
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Time to Reach Minimum Observed Plasma Concentration (Tmin) of Fruquintinib
Tmin of fruquintinib was reported.
PK evaluable population: all participants who received at least 1 dose of study drug and had a sufficient PK profile to derive at least 1 PK parameter. "Overall number of participants analyzed" signifies participants evaluable for this OM; "number analyzed" signifies participants evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Day 14; and for Dose Escalation Phase and Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Median
Full Range
hours
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Fruquintinib
AUC0-24 of fruquintinib was reported.
PK evaluable population:all participants who received at least 1 dose of study drug and had a sufficient PK profile to derive at least 1 PK parameter. "Overall number of participants analyzed" signifies participants evaluable for this OM; "number analyzed" signifies participants evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Days 1 and 14; and for Dose Escalation Phase, Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanogram per millimeter (h*ng/mL)
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Secondary
Dose Escalation and Expansion Phase: Apparent Clearance at Steady State (CL/Fss) of Fruquintinib
CL/Fss was calculated as Dose/AUC0-t. As planned, CL/Fss was assessed at Cycle 1 Days 14 and 21 after multiple dose administration in Dose Escalation Phase and Cohort A of Dose Expansion Phase; and at Cycle 1 Day 14 for Cohort B, C, D, E of Expansion Phase.
PK evaluable population:all participants who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. "Overall number of participants analyzed" signifies participants evaluable for this OM; "number analyzed" signifies participants evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Day 14; and for Dose Escalation Phase and Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Mean
Standard Deviation
milliliter per minute (mL/min)
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Secondary
Dose Escalation and Expansion Phase: Accumulation Ratio Based on Cmax of Fruquintinib
Accumulation ratio based on Cmax for Cycle 1 Day 14 was calculated as Day 14 Cmax /Day 1 Cmax and for Cycle 1 Day 21 was calculated as Day 21 Cmax /Day 1 Cmax. Accumulation ratio based on Cmax of fruquintinib was reported.
PK evaluable population: all participants who received at least 1 dose of study drug and had a sufficient PK profile to derive at least 1 PK parameter. Here, "overall number of participants analyzed" signifies participants evaluable for this OM; "number analyzed" signifies participants evaluable at specified timepoints. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Day 14; and for Dose Escalation Phase, Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Mean
Standard Deviation
ratio
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14 and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Secondary
Dose Escalation and Expansion Phase: Accumulation Ratio Based on AUC0-24 Hours of Fruquintinib
Accumulation ratio for Cycle 1 Day 14 was calculated as AUC0-24 at Day 14 divided by AUC0-24h at Day 1, and for Cycle 1 Day 21 was calculated as AUC0-24 at Day 21 divided by AUC0-24 at Day 1. Accumulation ratio based on AUC0-24 of fruquintinib was reported.
PK evaluable population included all participants who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM. As per planned analysis, PK data were collected and reported for all cohorts at Cycle 1 Day 14; and for Dose Escalation Phase and Cohort A of Expansion Phase at Cycle 1 Day 21 only.
Posted
Mean
Standard Deviation
ratio
Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14 and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Secondary
Dose Escalation and Expansion Phase: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with objective complete response (CR) or partial response (PR) response per RECIST version 1.1. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
The Efficacy Analysis Set included all participants who received at least 1 dose of fruquintinib, had a measurable lesion (target lesions >=10 mm) at the baseline tumor assessment, and either: 1) had at least 1 postbaseline tumor assessment; or 2) did not have post-dose tumor assessment but had clinical progression as noted by the Investigator; or died due to disease progression before their first postbaseline tumor scan.
Posted
Number
95% Confidence Interval
percentage of participants
From the first dose of study drug until first documentation of best overall response (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Secondary
Dose Escalation and Expansion Phase: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, confirmed PR or stable disease (SD) (for 7 weeks) per RECIST version 1.1. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined 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 progressive disease (PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study [this might include the baseline sum]).
The Efficacy Analysis Set included all participants who received at least 1 dose of fruquintinib, had a measurable lesion (target lesions >=10 mm) at the baseline tumor assessment, and either: 1) had at least 1 postbaseline tumor assessment; or 2) did not have post-dose tumor assessment but had clinical progression as noted by the Investigator; or died due to disease progression before their first postbaseline tumor scan.
Posted
Number
95% Confidence Interval
percentage of participants
From the first dose of study drug until first documentation of best overall response (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Duration of Response (DoR)
DoR was defined as the time (in months) from the date of the first objective response (CR or PR) until the date of the documented progression or of death, whichever comes first. DoR was only analyzed for participants whose best overall response (BOR) was either CR or PR. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 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 (this might include the baseline sum). DoR was calculated using the Kaplan-Meier method.
Efficacy Analysis Set was used for analysis. Here, "Overall number of participants analyzed" signifies participants who had CR or PR; & '0' in 'overall number of participants analyzed represents that DOR could only be analyzed in participants who achieved a response i.e., CR or PR. As no participant in the dose expansion cohorts A, D and E achieved any response, no DOR is available.
Posted
Median
95% Confidence Interval
months
From the date of the first objective response (CR or PR) until the date of the documented disease progression or of death, whichever comes first (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Secondary
Dose Escalation and Expansion Phase: Progression Free Survival (PFS)
PFS was defined as the time (in months) from date of first dosing until the date of an objective disease progression as per RECIST version 1.1 or death due to any cause, whichever comes first. PFS was determined using all the assessment data up until the last evaluable visit prior to or on the date of (i) disease progression as defined by RECIST version 1.1 or death; or (ii) withdrawal of consent; or (iii) receiving subsequent anti-cancer therapy, whichever is earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this might include the baseline sum). PFS was calculated using the Kaplan-Meier method.
The SAS included all participants who received at least 1 dose of the study drug.
Posted
Median
95% Confidence Interval
months
From date of first dose until the date of an objective disease progression or death due to any cause, whichever comes first (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Secondary
Dose Escalation and Expansion Phase: Overall Survival (OS)
OS was defined as the time interval (in months) between the first dose date and the date of death (any cause). OS was calculated using the Kaplan-Meier method.
The SAS included all participants who received at least 1 dose of the study drug.
Posted
Median
95% Confidence Interval
months
From first dose date to the date of death (due to any cause) (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Secondary
Dose Escalation and Expansion Phase: Percent Change From Baseline (PCFB) in Tumor Size
Tumor size was estimated using data on sum of diameters of target lesion. Percentage change in tumor size from baseline was determined for participants with measurable disease at baseline and derived by the percentage change in the sum of the diameters of target lesions (TLs) compared to baseline. Baseline was defined as the last evaluable tumor assessment result obtained prior to the first administration of study medication.
Efficacy Analysis Set: all participants who received at least 1 dose of fruquintinib, had a measurable lesion (target lesions >=10 mm) at baseline tumor assessment and either: 1) had at least 1 postbaseline tumor assessment; or 2) did not have post-dose tumor assessment but had clinical progression as noted by Investigator; or died due to disease progression before first postbaseline tumor scan. Overall number of participants analyzed signifies participants evaluable for this OM.
Posted
Mean
Standard Deviation
percent change
Baseline up to 29 months
ID
Title
Description
OG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Secondary
Dose Expansion Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study medication and no later than 37 days after the date of last study treatment. A SAE was any AE that had any of the following characteristics: Fatal (that was, the AE actually caused or led to death, except for deaths caused by the progress of disease); Life threatening (that was, AE, in view of the investigator, places participant at immediate risk of death); Required or prolonged inpatient hospitalization (excluding emergency or outpatient treatment); Resulted in persistent or significant disability/incapacity (that was, the AE resulted in substantial disruption of the participant's ability to conduct normal life functions).
The SAS included all participants who received at least 1 dose of the study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months)
ID
Title
Description
OG000
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG001
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Time Frame
From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months)
Description
The SAS included all participants who received at least 1 dose of the study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dose Escalation Phase: Fruquintinib 3 mg
Participants with advanced solid tumors of any type received fruquintinib 3 mg capsules (3 capsules, 1mg/capsule), once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
3
7
3
7
7
7
EG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
2
7
2
7
7
7
EG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
3
6
4
6
6
6
EG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
30
41
19
41
41
41
EG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
25
40
14
40
39
40
EG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
12
14
2
14
14
14
EG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
12
14
4
14
14
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acquired oesophageal web
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG0030 affected41 at risk
EG004
Large intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Kidney infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Death
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0003 affected7 at risk
EG0013 affected7 at risk
EG0025 affected6 at risk
EG00317 affected41 at risk
EG0045 affected40 at risk
EG0055 affected14 at risk
EG0064 affected14 at risk
Nausea
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0004 affected7 at risk
EG0014 affected7 at risk
EG0021 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0005 affected7 at risk
EG0013 affected7 at risk
EG0023 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0003 affected7 at risk
EG0013 affected7 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0004 affected7 at risk
EG0014 affected7 at risk
EG0023 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0013 affected7 at risk
EG0021 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0022 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0012 affected7 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Acquired oesophageal web
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Faeces pale
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0014 affected7 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Haemoglobin increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Protein total decreased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Troponin I increased
Investigations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0013 affected7 at risk
EG0025 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Vasculitis
Vascular disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0014 affected7 at risk
EG0022 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Jaw clicking
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0013 affected7 at risk
EG0022 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Axillary pain
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Device related thrombosis
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Tenderness
General disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0014 affected7 at risk
EG0024 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Bronchostenosis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0014 affected7 at risk
EG0022 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0023 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0014 affected7 at risk
EG0022 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0022 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Candida infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Localised infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Gingivitis
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hordeolum
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Otitis externa
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Pyuria
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Rash pustular
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0021 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Abdominal wall wound
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA version 25.1
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Brain neoplasm benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Skin neoplasm bleeding
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0007
OG0017
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG0007
OG0017
Participants with serious TEAEs
Title
Measurements
OG0003
OG0012
OG001
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0006
OG00141
OG00240
OG00314
OG00414
Title
Denominators
Categories
Title
Measurements
OG00053.33(4.68 to 100.00)
OG00161.04(45.59 to 76.49)
OG00255.64(39.87 to 71.41)
OG00329.30(1.91 to 56.70)
OG00438.46(12.02 to 64.91)
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0007
OG0017
OG0026
OG00341
OG00440
OG00514
OG00614
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00341
ParticipantsOG00440
ParticipantsOG00514
ParticipantsOG00614
Title
Measurements
OG00052.2± 24.2
OG001114± 27.5
OG00296.0± 23.0
OG003
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0007
OG0017
OG0026
OG00341
OG00440
OG00514
OG00614
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00341
ParticipantsOG00440
ParticipantsOG00514
ParticipantsOG00614
Title
Measurements
OG0002.07(1.03 to 21.2)
OG0011.95(0.917 to 25.0)
OG0021.96(1.00 to 13.8)
OG003
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0005
OG0016
OG0022
OG00334
OG00433
OG00512
OG00610
Title
Denominators
Categories
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
ParticipantsOG00433
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG000138± 28.3
OG001281± 101
OG002251± 114
OG003
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0005
OG0016
OG0022
OG00334
OG00433
OG00512
OG00610
Title
Denominators
Categories
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
ParticipantsOG00433
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG0000.00(0.00 to 7.00)
OG0010.508(0.00 to 27.8)
OG0023.57(0.00 to 7.13)
OG003
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0006
OG0017
OG0023
OG00334
OG00433
OG00512
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00511
ParticipantsOG0068
Title
Measurements
OG000912± 21.5
OG0012010± 19.2
OG0021340± 25.6
OG003
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0004
OG0016
OG0022
OG00334
OG00433
OG00512
OG00610
Title
Denominators
Categories
Cycle 1 Day 14
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
ParticipantsOG00433
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG00014.4± 2.90
OG00111.1± 4.04
OG00214.1± 7.31
OG003
Cycle 1 Day 21
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0005
OG0016
OG0022
OG00334
OG00433
OG00512
OG00610
Title
Denominators
Categories
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00334
ParticipantsOG00433
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG0004.06± 1.42
OG0013.66± 1.42
OG0023.57± 0.232
OG003
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0005
OG0016
OG0021
OG00328
OG00428
OG0059
OG0066
Title
Denominators
Categories
Cycle 1 Day 14
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG00328
ParticipantsOG00428
ParticipantsOG0059
ParticipantsOG0066
Title
Measurements
OG0004.24± 1.21
OG0014.19± 1.19
OG0024.04± NAStandard Deviation was not calculated due to single participant.
OG003
Cycle 1 Day 21
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0030
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG00341
OG00439
OG00510
OG00613
Title
Denominators
Categories
Title
Measurements
OG00016.7(0.42 to 64.12)
OG00114.3(0.36 to 57.87)
OG0020.0(0.00 to 45.93)
OG0032.4(0.06 to 12.86)
OG0045.1(0.63 to 17.32)
OG0050.0(0.00 to 30.85)
OG0060.0(0.00 to 24.71)
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG00341
OG00439
OG00510
OG00613
Title
Denominators
Categories
Title
Measurements
OG00066.7(22.28 to 95.67)
OG00171.4(29.04 to 96.33)
OG00266.7(22.28 to 95.67)
OG00368.3(51.91 to 81.92)
OG00459.0(42.10 to 74.43)
OG00560.0(26.24 to 87.84)
OG00638.5(13.86 to 68.42)
OG001
Dose Escalation Phase: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0001
OG0011
OG0020
OG0031
OG0042
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG0007.56(NA to NA)95% Confidence Interval (CI) was not determined due to insufficient numbers of participants with events.
OG001NA(NA to NA)Median and 95% CI was not determined due to insufficient numbers of participants with events.
OG0034.04(NA to NA)95% CI was not determined due to insufficient numbers of participants with events.
OG004NA(5.65 to NA)Median and upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0007
OG0017
OG0026
OG00341
OG00440
OG00514
OG00614
Title
Denominators
Categories
Title
Measurements
OG0006.90(0.56 to NA)Upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
OG001NA(3.65 to NA)Median and upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
OG0025.49(1.77 to NA)Upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
OG0034.67(2.76 to 5.32)
OG0043.75(2.00 to 5.49)
OG0052.43(1.74 to 5.06)
OG0061.87(1.15 to 3.94)
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0007
OG0017
OG0026
OG00341
OG00440
OG00514
OG00614
Title
Denominators
Categories
Title
Measurements
OG00022.70(0.56 to NA)Upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
OG00119.58(6.05 to NA)Upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
OG0026.03(4.24 to NA)Upper limit of 95% CI was not determined due to insufficient numbers of participants with events.
OG0038.71(6.57 to 11.47)
OG00410.64(5.16 to 19.32)
OG00512.06(6.21 to 13.24)
OG0068.74(3.78 to 15.93)
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg
Participants with advanced solid tumors of any type received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG005
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG006
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG00319
OG00415
OG0053
OG0063
Title
Denominators
Categories
Title
Measurements
OG0005.41± NAStandard Deviation was not calculated for singe participant.
OG001-20.70± 16.485
OG002-12.92± 25.919
OG0037.40± 23.713
OG00419.23± 20.808
OG005-8.07± 8.574
OG0069.82± 16.824
Participants with mCRC and prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG002
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg
Participants with mCRC and no prior treatment with trifluridine, tipiracil or regorafenib received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG003
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg
Participants with HR+, HER2-negative mBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
OG004
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg
Participants with TNBC received fruquintinib 5 mg capsule, once daily, 3 weeks on, 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by Investigator, whichever occurred first.
Units
Counts
Participants
OG0006
OG00141
OG00240
OG00314
OG00414
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG0006
OG00141
OG00239
OG00314
OG00414
Participants with serious TEAEs
Title
Measurements
OG0004
OG00119
OG00214
OG003
0 affected
40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
11 affected
41 at risk
EG0046 affected40 at risk
EG0057 affected14 at risk
EG0067 affected14 at risk
11 affected
41 at risk
EG0046 affected40 at risk
EG0056 affected14 at risk
EG0063 affected14 at risk
8 affected
41 at risk
EG0047 affected40 at risk
EG0055 affected14 at risk
EG0063 affected14 at risk
7 affected
41 at risk
EG0043 affected40 at risk
EG0052 affected14 at risk
EG0064 affected14 at risk
8 affected
41 at risk
EG0043 affected40 at risk
EG0054 affected14 at risk
EG0063 affected14 at risk
2 affected
41 at risk
EG0043 affected40 at risk
EG0056 affected14 at risk
EG0062 affected14 at risk
5 affected
41 at risk
EG0040 affected40 at risk
EG0053 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0053 affected14 at risk
EG0061 affected14 at risk
2 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0053 affected14 at risk
EG0061 affected14 at risk
2 affected
41 at risk
EG0042 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
11 affected
41 at risk
EG00411 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
10 affected
41 at risk
EG0049 affected40 at risk
EG0051 affected14 at risk
EG0063 affected14 at risk
9 affected
41 at risk
EG0044 affected40 at risk
EG0051 affected14 at risk
EG0063 affected14 at risk
6 affected
41 at risk
EG0049 affected40 at risk
EG0052 affected14 at risk
EG0061 affected14 at risk
7 affected
41 at risk
EG0049 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
9 affected
41 at risk
EG0045 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
7 affected
41 at risk
EG0048 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0049 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
6 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
4 affected
41 at risk
EG0044 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
4 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
4 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0062 affected14 at risk
3 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0062 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
20 affected
41 at risk
EG00429 affected40 at risk
EG0059 affected14 at risk
EG0066 affected14 at risk
3 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0063 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
14 affected
41 at risk
EG00410 affected40 at risk
EG0054 affected14 at risk
EG0062 affected14 at risk
11 affected
41 at risk
EG00410 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
8 affected
41 at risk
EG00411 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
6 affected
41 at risk
EG0049 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
6 affected
41 at risk
EG0043 affected40 at risk
EG0051 affected14 at risk
EG0062 affected14 at risk
6 affected
41 at risk
EG0043 affected40 at risk
EG0051 affected14 at risk
EG0062 affected14 at risk
2 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
5 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
2 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0062 affected14 at risk
1 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
7 affected
41 at risk
EG0048 affected40 at risk
EG0056 affected14 at risk
EG0065 affected14 at risk
2 affected
41 at risk
EG00413 affected40 at risk
EG0055 affected14 at risk
EG0064 affected14 at risk
4 affected
41 at risk
EG0046 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0043 affected40 at risk
EG0052 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0053 affected14 at risk
EG0062 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
22 affected
41 at risk
EG00412 affected40 at risk
EG0058 affected14 at risk
EG0065 affected14 at risk
2 affected
41 at risk
EG0044 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0042 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0062 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
2 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
13 affected
41 at risk
EG00410 affected40 at risk
EG0055 affected14 at risk
EG0063 affected14 at risk
7 affected
41 at risk
EG0042 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0045 affected40 at risk
EG0051 affected14 at risk
EG0062 affected14 at risk
2 affected
41 at risk
EG0042 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
11 affected
41 at risk
EG0046 affected40 at risk
EG0055 affected14 at risk
EG0067 affected14 at risk
4 affected
41 at risk
EG0042 affected40 at risk
EG0052 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0043 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
20 affected
41 at risk
EG00416 affected40 at risk
EG0055 affected14 at risk
EG0063 affected14 at risk
4 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
12 affected
41 at risk
EG0049 affected40 at risk
EG0054 affected14 at risk
EG0062 affected14 at risk
3 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0063 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0063 affected14 at risk
1 affected
41 at risk
EG0043 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
8 affected
41 at risk
EG0043 affected40 at risk
EG0054 affected14 at risk
EG0063 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
7 affected
41 at risk
EG00411 affected40 at risk
EG0056 affected14 at risk
EG0064 affected14 at risk
1 affected
41 at risk
EG0042 affected40 at risk
EG0052 affected14 at risk
EG0062 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0052 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0046 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0043 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
3 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
4 affected
41 at risk
EG0043 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0052 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0041 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0044 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0041 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
6 affected
41 at risk
EG0044 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
3 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
2 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0042 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0051 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
1 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0060 affected14 at risk
0 affected
41 at risk
EG0040 affected40 at risk
EG0050 affected14 at risk
EG0061 affected14 at risk
85.2
± 32.1
OG00489.0± 43.2
OG005104± 37.0
OG006105± 36.5
Participants
OG004
33
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG000198± 9.8
OG001403± 33.7
OG002336± 50.9
OG003271± 26.5
OG004293± 27.1
OG005331± 36.1
OG006352± 23.4
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000205± 12.8
OG001390± 19.1
OG002238± NAGeometric Coefficient of Variation was not calculated due to single participant.
2.25
(0.917 to 23.8)
OG0042.04(0.983 to 2.04)
OG0052.00(1.00 to 18.4)
OG0062.01(1.75 to 23.9)
Participants
OG004
33
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG0001.03(0.967 to 1.92)
OG0012.00(1.97 to 7.05)
OG0021.52(1.00 to 2.03)
OG0032.03(0.00 to 26.1)
OG0042.00(0.933 to 7.18)
OG0051.86(0.917 to 7.00)
OG0061.84(0.933 to 7.00)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0001.83(0.917 to 1.98)
OG0012.00(1.88 to 4.08)
OG0021.00(NA to NA)Full Range (minimum-maximum) was not calculated due to single participant.
193
± 57.3
OG004204± 63.2
OG005227± 98.4
OG006249± 72.1
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000140± 27.0
OG001283± 81.0
OG002182± NAStandard Deviation was not calculated due to single participant.
0.00
(0.00 to 25.6)
OG0040.00(0.00 to 28.2)
OG0050.00(0.00 to 23.9)
OG0060.458(0.00 to 22.0)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0007.00(0.00 to 25.6)
OG0013.54(0.00 to 24.9)
OG0027.00(NA to NA)Full Range (minimum-maximum) was not calculated due to single participant.
1384
± 39.0
OG0041550± 46.5
OG0051821± 31.5
OG0061739± 39.8
Participants
OG004
33
ParticipantsOG00512
ParticipantsOG00610
Title
Measurements
OG0003694± 17.1
OG0018249± 35.2
OG0026507± 53.7
OG0035338± 28.9
OG0045833± 27.3
OG0056135± 40.1
OG0066957± 25.1
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0003731± 22.5
OG0017740± 26.7
OG0024995± NAGeometric Coefficient of Variation was not calculated due to single participant.
16.3
± 5.16
OG00414.8± 3.92
OG00514.7± 7.18
OG00612.3± 2.80
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00014.1± 3.07
OG00111.3± 2.83
OG00217.5± NAStandard Deviation was not calculated due to single participant.
3.32
± 1.21
OG0043.44± 1.36
OG0053.22± 1.38
OG0063.40± 0.963
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0004.22± 1.45
OG0013.47± 1.22
OG0023.40± NAStandard Deviation was not calculated due to single participant.
3.87
± 1.22
OG0044.38± 3.08
OG0053.73± 1.51
OG0064.37± 1.70
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0004.36± 1.53
OG0013.90± 0.964
OG0024.43± NAStandard Deviation was not calculated due to single participant.