A Study of HMPL-306 in Advanced Hematological Malignancie... | NCT04764474 | Trialant
NCT04764474
Sponsor
Hutchmed
Status
Terminated
Last Update Posted
Jan 29, 2026Actual
Enrollment
46Actual
Phase
Phase 1
Conditions
Isocitrate Dehydrogenase Gene Mutation
Interventions
HMPL-306
Countries
United States
Spain
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04764474
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2020-306-GLOB1
Secondary IDs
Not provided
Brief Title
A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH
Official Title
A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies With Isocitrate Dehydrogenase (IDH) Mutations
Acronym
Not provided
Organization
HutchmedINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns
Expanded Access Info
No
Start Date
Apr 12, 2021Actual
Primary Completion Date
Jan 15, 2025Actual
Completion Date
Jan 15, 2025Actual
First Submitted Date
Jan 19, 2021
First Submission Date that Met QC Criteria
Feb 17, 2021
First Posted Date
Feb 21, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2025
Results First Submitted that Met QC Criteria
Jan 28, 2026
Results First Posted Date
Jan 29, 2026Actual
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
Jan 28, 2026
Last Update Posted Date
Jan 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
HutchmedINDUSTRY
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 single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations.
Detailed Description
HMPL-306 is a dual IDH1/2 inhibitor
This is a phase 1, open-label, multicenter, single-arm study to evaluate safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 administered orally in treatment of subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations (or co-mutations).
The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). The dose-escalation part will determine the MTD/R2PD. The dose-expansion part will administer the MTD/RP2D to subjects with mIDH-positive AML
Conditions Module
Conditions
Isocitrate Dehydrogenase Gene Mutation
Keywords
Acute Myeloid Leukemia
IDH Mutation
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
46Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment
Experimental
All patients will be administered HMPL-306 orally QD
Drug: HMPL-306
Interventions
Name
Type
Description
Arm Group Labels
Other Names
HMPL-306
Drug
Administered orally QD in a 28-day continuous dosing treatment cycle
Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of HMPL-306
RP2D determination took the following criteria under consideration: determination of maximum tolerated dose (MTD) achieved during the dose escalation part and assessment of safety, PK and pharmacodynamics (PD).
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
Dose Escalation Part: Number of Patients With Dose-Limiting Toxicities (DLTs)
DLT was defined as occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless clearly unrelated to the study drug as per investigator's discretion: nonhematologic toxicity: TEAEs of Grade >=4, Grade >=3 with the exception of those that resolved within 72 hours (h) of onset; hematologic toxicity with the exception of neutropenia or thrombocytopenia that occurred with active leukemic disease: Grade 3 or 4 neutropenia lasting more than 7 days, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or any requirement for platelets (PLT) transfusion, Grade 3 or greater febrile neutropenia defined as absolute neutrophil count (ANC) 1000 per cubic millimeter with a single temperature of >38.3 degree Celsius (°C) or a sustained temperature of >=38°C for more than 1 h; any TEAE requiring a dose delay of >=14 days or cases of confirmed Hy's law.
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
Number of Patients With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
AE:unfavorable and unintended sign,symptom or disease temporally associated with use of study drug or other protocol-imposed intervention, whether or not considered related to study drug. SAE:AE that resulted in death,life-threatening AE,inpatient hospitalization/prolongation of existing hospitalization,persistent/significant incapacity or substantial disruption of ability to conduct normal life functions, abnormal pregnancy outcome in child born to female patient or female partner of male patient exposed to study drug or was important medical event that jeopardized patient and required medical/surgical intervention to prevent above outcome. TEAE:AE with onset on/after start of study drug until 30 days after last dose or prior to start of subsequent anti-tumor therapy, or AE with onset before start of study drug but worsened in severity after study drug administration, or AE onset after 30 days after last dose or after start of subsequent anti-tumor therapy and treatment-related SAEs.
Secondary Outcomes
Measure
Description
Time Frame
Number of Patients With Best Overall Response (BOR)
BOR was defined as the best response during the anti-tumor evaluation period, which was determined using time point responses (TPRs) from date of the first dose of study drug from Cycle 1 in continuous cycle up until the last evaluable TPR prior to or on the date of PD/relapse according to the 2017 European LeukemiaNet criteria, or death; or withdrawal of consent or lost to follow-up; or receiving subsequent anti-cancer therapy, whichever was earlier. Number of patients with BOR [complete response (CR), CR with negative minimal residual disease (CRmrd-), CR with partial hematological recovery (CRh), CR with incomplete count (CRi), morphologic leukemia-free state (MLFS), partial response (PR), stable disease (SD), and PD] are reported.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Subjects may be enrolled in this study only if they satisfy all the following criteria (NOTE: This is not an exhaustive list):
Subjects aged ≥18 years.
ECOG performance status ≤ 2
Subjects with advanced relapsed, refractory, or resistant hematological malignancies, as defined below:
Part 1:
Subjects with documented IDH mutation per local or institutional next generation sequence (NGS).
Subjects must be refractory to or intolerant of established therapies.
Subjects who have received prior IDH inhibitor treatment may be enrolled in the escalation phase.
Part 2:
Subjects with documented IDH mutation of any of these subsets: IDH1 (R132C), IDH1 (R132H), IDH (R140Q), and IDH2 (R172K), including co-mutations and any combination thereof per local and institutional NGS.
Patients must have received at least 1 prior line of therapy with an IDH inhibitor. An established standard of care with proven benefit for which the patient is eligible, must not be available at the time of enrollment.
Patients with AML must not have standard therapeutic options available (including IDH inhibitors where approved) and have the following:
i. Relapsed AML unsuitable for intensive chemotherapy or venetoclax-based regimen or target agents;
ii. Primary refractory AML unsuitable for intensive chemotherapy or venetoclax-based regimen or target agents.
iii. Relapsed/refractory AML that has progressed on prior IDH treatment
Key Exclusion Criteria:
Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):
Subjects who received an investigational agent <14 days prior to their first day of study drug administration.
Subjects who are pregnant or breastfeeding.
Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever >38.3°C during screening visits or on their first day of study drug administration.
Subjects with some current or prior heart conditions.
Subjects taking medications that are known to prolong the QT interval may not be eligible.
Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
Some subjects with some current or prior gastrointestinal or liver diseases.
Subjects with inadequate organ function as defined by the protocol.
Subjects with a medical condition, physical examination finding, or clinical laboratory finding that, in the Investigators opinion, contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subject at high risk from treatment complications.
Subjects with a known hypersensitivity to HMPL-306 or to any of its excipients.
Subjects with presence of second primary malignant tumors within the last 2 years, with the exception of the following, if medically controlled: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast.
Part 2 Only: The time since the last dose of prior IDH inhibitor treatment is within 30 days prior to the first day of study drug administration
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
Bo Zhang
Hutchison Medipharma Limited
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
Orange
California
92868
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate participant flow period was created for dose expansion part. Study was terminated based on strategic evaluation of clinical development of HMPL-306 with no safety concerns. Dose levels increase from 1 to 8, with Dose Level 1 being the lowest dose and Dose Level 8 the highest dose.
Recruitment Details
This Phase 1, 2-part, open-label study was conducted in patients with advanced relapsed/refractory or resistant hematological malignancies that harbor isocitrate dehydrogenase mutations. The study consisted of dose escalation part (Part 1) and dose expansion part (Part 2). A total of 46 patients were enrolled in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the pharmacokinetic (PK) week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then once daily (QD) from Cycle 1 Day 1 until disease progression (PD), death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
FG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG00211 subjects
FG0037 subjects
FG0046 subjects
FG0054 subjects
FG0064 subjects
FG0078 subjects1 patient was enrolled in dose expansion part at Dose Level 8 and all data of this patient were pooled in the dose escalation part at Dose Level 8 cohort (Cohort 8) for data analysis.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG00211 subjects
FG0037 subjects
FG004
Type
Comment
Reasons
Death
FG0001 subjects
FG0013 subjects
FG0027 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The safety analysis set included all enrolled patients who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 Part: Recommended Phase 2 Dose (RP2D) of HMPL-306
RP2D determination took the following criteria under consideration: determination of maximum tolerated dose (MTD) achieved during the dose escalation part and assessment of safety, PK and pharmacodynamics (PD).
The safety analysis set included all enrolled patients who received at least 1 dose of study drug.
Posted
Number
mg
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Part: Cohorts 1 to 8: HMPL-306
All patients enrolled in the dose escalation part (Cohorts 1 to 8) were included in this arm.
Units
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse events were collected from the first dose of study drug (Day 1 of the PK week) up to 30 days after the last dose of study drug, or prior to the start of a subsequent anti-tumor therapy (whichever came first), approximately 25.25 months. All-cause mortality (deaths) were collected from the first dose of study drug (Day 1 of the PK week) up to end of follow-up, approximately 45 months.
Description
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
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
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
More Info Module
Limitations and Caveats
The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns.
From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 25.25 months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Objective Response Rate (ORR)
ORR was defined as the percentage of patients with BOR being CRmrd-, CR, CRh, CRi, MLFS or PR. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Time to Objective Response (TTOR)
TTOR was defined as the time from the date of first study drug administration from Cycle 1 in continuous cycle to the date of first objective response (CRmrd-, CR, CRh, CRi, MLFS, or PR). CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Duration of Objective Response (DoOR)
DoOR was defined as the time from the first occurrence of objective response (CRmrd-, CR, CRh, CRi, MLFS, or PR) until PD, relapse, or death due to any cause, whichever came first. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Clinical Benefit Rate (CBR)
CBR was defined as the percentage of patients with BOR being CRmrd-, CR, CRh, CRi, MLFS, PR, or SD lasting for 3 cycles. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%. SD: Not met criteria for CR, CRi, CRmrd-, MLFS, PR, or PD.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Progression-Free Survival (PFS)
PFS was defined as the time from the start of study drug from Cycle 1 in continuous cycle to PD, or relapse, or death due to any cause, whichever occurred first. PD was defined as increase in bone marrow blast percentage and/or absolute peripheral blood blast cells: a) myeloblasts percentage increased from baseline by >50% (if blast cells at baseline were <30%, net increased value needs to be >=15%) or myeloblasts percentage >70% continued for at least 3 months; ANC was not seen to be improved by at least 100%, reached (>0.5x10^9/L and/or PLT reached >50x10^9/L, without blood transfusion); b) the absolute peripheral blood blast cell count (WBCxblast cell ratio) increased by >50% and reached >25x10^9/L (without differentiation syndrome); or new extramedullary diseases.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Overall Survival (OS)
OS was defined as the time from the start of study drug from Cycle 1 in continuous cycle until the date of death due to any cause.
From the first dose of study drug (Day 1) up to date of death due to any cause, approximately 45 months
Event-Free Survival (EFS)
EFS was defined as the time from date of first study drug administration from Cycle 1 in continuous cycle to treatment failure, relapse from CR (including CRmrd-, CR, CRh and CRi), or death due to any cause, whichever occurred first. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. Treatment failure was defined as failure to achieve CR (including CRmrd-, CR, CRh, CRi) by Week 24. Patients who did not achieve CR (including CRmrd-, CR, CRh, CRi) by Week 24 were considered to have had an event at Day 1 of first study drug administration from Cycle 1 (excluding single oral dose from PK week). For remaining CR responders (including CRmrd-, CR, CRh and CRi), event time was time of either disease relapse or death due to any cause, whichever occurred first.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
Number of Patients With Post-Baseline Transfusion Independence (TI)
Post-baseline TI was defined as the absence of red blood cell and platelet transfusions for a pre-specified time during treatment period which was defined from the first dose of study drug administration from Cycle 1 in continuous cycle to 30 days after the last dose date or prior to the start of a subsequent anti-tumor therapy (whichever came first). Number of patients with post-baseline TI for >=4 weeks and >=8 weeks is presented.
From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 25.25 months
Plasma Concentrations of HMPL-306
Blood samples were collected at the specified timepoints to determine plasma concentrations of HMPL-306.
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) of HMPL-306
Blood samples were collected at the specified timepoints to determine Cmax of HMPL-306.
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
Time to Reach the Maximum Plasma Concentration (Tmax) of HMPL-306
Blood samples were collected at the specified timepoints to determine Tmax of HMPL-306.
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of HMPL-306
Blood samples were collected at the specified timepoints to determine AUC0-24 of HMPL-306.
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
Maximum Inhibition Rate of Plasma 2-Hydroxyglutaric Acid (2-HG)
Blood samples were collected at the specified timepoints to determine plasma concentrations of 2-HG which was a PD marker. The maximum inhibition rate for patients in different dose groups are presented.
From PK Week Day 2 until end of treatment, approximately 24.25 months
Winship Cancer Institute - Emory University
Atlanta
Georgia
30322
United States
University of Massachusetts Medical School
Worcester
Massachusetts
01655
United States
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
08901
United States
The Ohio State University Comprehensive Cancer Center
Columbus
Ohio
43210
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Froedtert-Medical College of WI
Milwaukee
Wisconsin
53226
United States
Clinica Universidad de Navarra
Pamplona
Navarre
31008
Spain
Hospital Clinico Universitario de Valencia
Valencia
Valencia
46010
Spain
Hospital Universitario La Fe
Valencia
Valencia
46026
Spain
Hospital Universitario Vall d'Hebron
Barcelona
08035
Spain
Institut Catala d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
Barcelona
08908
Spain
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Madrid
28040
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Universitario de Salamanca
Salamanca
58-182
Spain
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
6 subjects
FG0054 subjects
FG0064 subjects
FG0078 subjects
5 subjects
FG0045 subjects
FG0053 subjects
FG0062 subjects
FG0074 subjects
Sponsor terminated study
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0073 subjects
Withdrawal of consent
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
BG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
BG008
Total
Total of all reporting groups
3
BG0013
BG00211
BG0037
BG0046
BG0054
BG0064
BG0078
BG00846
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065.7± 5.69
BG00165.0± 10.15
BG00272.3± 6.92
BG00368.7± 5.68
BG00469.2± 12.04
BG00566.5± 17.71
BG00667.3± 10.90
BG00770.4± 13.46
BG00869.2± 9.98
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG0026
BG0032
BG0043
BG0051
BG0062
BG0074
BG00821
Male
BG0001
BG0012
BG0025
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG0021
BG0035
BG0041
BG0051
BG0060
BG0073
BG00813
Not Hispanic or Latino
BG0003
BG0011
BG0028
BG0032
BG004
Unknown or Not Reported
BG0000
BG0010
BG0022
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0071
BG0082
White
BG0003
BG0012
BG0028
BG0037
BG004
Unknown or Not Reported
BG0000
BG0011
BG0023
BG0030
BG004
Counts
Participants
OG00045
Title
Denominators
Categories
Title
Measurements
OG000NAThe MTD was not reached up to the explored highest dose of Dose Level 8 and the RP2D was not determined in the study.
Primary
Dose Escalation Part: Number of Patients With Dose-Limiting Toxicities (DLTs)
DLT was defined as occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless clearly unrelated to the study drug as per investigator's discretion: nonhematologic toxicity: TEAEs of Grade >=4, Grade >=3 with the exception of those that resolved within 72 hours (h) of onset; hematologic toxicity with the exception of neutropenia or thrombocytopenia that occurred with active leukemic disease: Grade 3 or 4 neutropenia lasting more than 7 days, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or any requirement for platelets (PLT) transfusion, Grade 3 or greater febrile neutropenia defined as absolute neutrophil count (ANC) 1000 per cubic millimeter with a single temperature of >38.3 degree Celsius (°C) or a sustained temperature of >=38°C for more than 1 h; any TEAE requiring a dose delay of >=14 days or cases of confirmed Hy's law.
The DLT-evaluable analysis set included all patients provided by HUTCHMED clinical team based on the decision made with the safety review committee (SRC) after SRC meeting for each cohort during the dose escalation part. A patient was DLT-evaluable if the patient had received at least 75% of the assigned dose of study drug during the DLT assessment window or had not completed DLT assessment period due to a DLT.
Posted
Count of Participants
Participants
No
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Patients With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
AE:unfavorable and unintended sign,symptom or disease temporally associated with use of study drug or other protocol-imposed intervention, whether or not considered related to study drug. SAE:AE that resulted in death,life-threatening AE,inpatient hospitalization/prolongation of existing hospitalization,persistent/significant incapacity or substantial disruption of ability to conduct normal life functions, abnormal pregnancy outcome in child born to female patient or female partner of male patient exposed to study drug or was important medical event that jeopardized patient and required medical/surgical intervention to prevent above outcome. TEAE:AE with onset on/after start of study drug until 30 days after last dose or prior to start of subsequent anti-tumor therapy, or AE with onset before start of study drug but worsened in severity after study drug administration, or AE onset after 30 days after last dose or after start of subsequent anti-tumor therapy and treatment-related SAEs.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Count of Participants
Participants
No
From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 25.25 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0003
OG0013
OG00211
OG003
Secondary
Number of Patients With Best Overall Response (BOR)
BOR was defined as the best response during the anti-tumor evaluation period, which was determined using time point responses (TPRs) from date of the first dose of study drug from Cycle 1 in continuous cycle up until the last evaluable TPR prior to or on the date of PD/relapse according to the 2017 European LeukemiaNet criteria, or death; or withdrawal of consent or lost to follow-up; or receiving subsequent anti-cancer therapy, whichever was earlier. Number of patients with BOR [complete response (CR), CR with negative minimal residual disease (CRmrd-), CR with partial hematological recovery (CRh), CR with incomplete count (CRi), morphologic leukemia-free state (MLFS), partial response (PR), stable disease (SD), and PD] are reported.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Count of Participants
Participants
No
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
CRmrd-
OG0000
OG0010
OG0020
OG003
Secondary
Objective Response Rate (ORR)
ORR was defined as the percentage of patients with BOR being CRmrd-, CR, CRh, CRi, MLFS or PR. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limits of 95% confidence interval (CI) were not estimable as there were no patients with CRmrd-, CR, CRh, CRi, MLFS or PR at study termination.
OG0010(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable as there were no patients with CRmrd-, CR, CRh, CRi, MLFS or PR at study termination.
OG002
Secondary
Time to Objective Response (TTOR)
TTOR was defined as the time from the date of first study drug administration from Cycle 1 in continuous cycle to the date of first objective response (CRmrd-, CR, CRh, CRi, MLFS, or PR). CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%.
Efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from PK week for dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with objective response were included in analysis.
Posted
Median
Full Range
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0000
OG0010
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0023.680(3.09 to 5.45)
OG0032.316(0.95 to 3.68)
OG0044.600(1.77 to 4.90)
OG006
Secondary
Duration of Objective Response (DoOR)
DoOR was defined as the time from the first occurrence of objective response (CRmrd-, CR, CRh, CRi, MLFS, or PR) until PD, relapse, or death due to any cause, whichever came first. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%.
Efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from PK week for dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with objective response were included in analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0000
OG0010
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0025.19(1.87 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG00315.28(7.43 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG004
Secondary
Clinical Benefit Rate (CBR)
CBR was defined as the percentage of patients with BOR being CRmrd-, CR, CRh, CRi, MLFS, PR, or SD lasting for 3 cycles. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. MLFS: myeloblast <5%, blast cells without Auer bodies, no extramedullary lesion, no hematological recovery requirements. PR: met all hematological criteria for CR, percentage of myeloblasts decreased from baseline by least 50% and reached 5% to 25%. SD: Not met criteria for CR, CRi, CRmrd-, MLFS, PR, or PD.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.8 to 90.6)
OG0010(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable as there were no patients with CRmrd-, CR, CRh, CRi, MLFS, PR, or SD lasting for 3 cycles at study termination.
OG002
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time from the start of study drug from Cycle 1 in continuous cycle to PD, or relapse, or death due to any cause, whichever occurred first. PD was defined as increase in bone marrow blast percentage and/or absolute peripheral blood blast cells: a) myeloblasts percentage increased from baseline by >50% (if blast cells at baseline were <30%, net increased value needs to be >=15%) or myeloblasts percentage >70% continued for at least 3 months; ANC was not seen to be improved by at least 100%, reached (>0.5x10^9/L and/or PLT reached >50x10^9/L, without blood transfusion); b) the absolute peripheral blood blast cell count (WBCxblast cell ratio) increased by >50% and reached >25x10^9/L (without differentiation syndrome); or new extramedullary diseases.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.80(NA to NA)NA indicates that the upper and lower limits of 95% CI were not estimable, as there were insufficient numbers of patients with 2/3 patients censored prior to any event.
OG0013.42(1.87 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG002
Secondary
Overall Survival (OS)
OS was defined as the time from the start of study drug from Cycle 1 in continuous cycle until the date of death due to any cause.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Median
95% Confidence Interval
months
From the first dose of study drug (Day 1) up to date of death due to any cause, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.80(NA to NA)NA indicates that the upper and lower limits of 95% CI were not estimable, as there were insufficient numbers of patients with 2/3 patients censored prior to any event.
OG0014.57(3.42 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG002
Secondary
Event-Free Survival (EFS)
EFS was defined as the time from date of first study drug administration from Cycle 1 in continuous cycle to treatment failure, relapse from CR (including CRmrd-, CR, CRh and CRi), or death due to any cause, whichever occurred first. CR: myeloblast <5%, blast cells without Auer bodies, no blast cells in peripheral blood, no extramedullary lesion, ANC >=1.0x10^9/L, PLT >=100x10^9/L. CRmrd-: CR with negative RT-qPCR or CR with negative MFC. CRi: met all other criteria of CR but ANC <1.0x10^9/L or PLT <100x10^9/L. Treatment failure was defined as failure to achieve CR (including CRmrd-, CR, CRh, CRi) by Week 24. Patients who did not achieve CR (including CRmrd-, CR, CRh, CRi) by Week 24 were considered to have had an event at Day 1 of first study drug administration from Cycle 1 (excluding single oral dose from PK week). For remaining CR responders (including CRmrd-, CR, CRh and CRi), event time was time of either disease relapse or death due to any cause, whichever occurred first.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-14 days) thereafter until end of treatment, or end of efficacy follow-up period, approximately 45 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.03(NA to NA)NA indicates that the upper and lower limits of 95% CI were not estimable, as all the patients in this cohort experienced an event of treatment failure at Day 1 (0.03 months).
OG0010.03(NA to NA)NA indicates that the upper and lower limits of 95% CI were not estimable, as all the patients in this cohort experienced an event of treatment failure at Day 1 (0.03 months).
OG002
Secondary
Number of Patients With Post-Baseline Transfusion Independence (TI)
Post-baseline TI was defined as the absence of red blood cell and platelet transfusions for a pre-specified time during treatment period which was defined from the first dose of study drug administration from Cycle 1 in continuous cycle to 30 days after the last dose date or prior to the start of a subsequent anti-tumor therapy (whichever came first). Number of patients with post-baseline TI for >=4 weeks and >=8 weeks is presented.
The efficacy analysis set included all enrolled patients who received at least 1 dose of study drug from Cycle 1 Day 1 in continuous cycle (i.e., excluding single oral dose from the PK week for the dose escalation part). As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part.
Posted
Count of Participants
Participants
No
From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 25.25 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Post-baseline TI for >=4 weeks
Title
Measurements
OG0003
OG0013
OG0027
OG003
Secondary
Plasma Concentrations of HMPL-306
Blood samples were collected at the specified timepoints to determine plasma concentrations of HMPL-306.
The PK concentration analysis set included all patients who received at least 1 dose of the study drug and had at least 1 measurable plasma concentration data point. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
PK Week: Pre-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of HMPL-306
Blood samples were collected at the specified timepoints to determine Cmax of HMPL-306.
The PK parameters analysis set included all patients who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with data collected at specified timepoints are reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
PK Week Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Time to Reach the Maximum Plasma Concentration (Tmax) of HMPL-306
Blood samples were collected at the specified timepoints to determine Tmax of HMPL-306.
The PK parameters analysis set included all patients who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
PK Week Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of HMPL-306
Blood samples were collected at the specified timepoints to determine AUC0-24 of HMPL-306.
The PK parameters analysis set included all patients who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with data collected at specified timepoints are reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
PK Week: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 PK week; Cycle 2 Day 1: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
PK Week Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Maximum Inhibition Rate of Plasma 2-Hydroxyglutaric Acid (2-HG)
Blood samples were collected at the specified timepoints to determine plasma concentrations of 2-HG which was a PD marker. The maximum inhibition rate for patients in different dose groups are presented.
The PD analysis set included all patients with at least 1 quantifiable level of 2-HG in plasma. As only 1 patient was enrolled in dose expansion part, all data of patient were pooled in dose escalation part at Dose Level 8 cohort (Cohort 8) for the data analysis. Thus, no separate arm was created for dose expansion part. Only patients with data collected are reported.
Posted
Mean
Standard Deviation
percentage of inhibition
From PK Week Day 2 until end of treatment, approximately 24.25 months
ID
Title
Description
OG000
Cohort 1: HMPL-306 Dose Level 1
Patients received HMPL-306 Dose Level 1 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
OG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00065.85± 24.70
OG00171.49± 33.07
OG00261.23± 33.67
OG003
1
3
3
3
3
3
EG001
Cohort 2: HMPL-306 Dose Level 2
Patients received HMPL-306 Dose Level 2 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
3
3
1
3
3
3
EG002
Cohort 3: HMPL-306 Dose Level 3
Patients received HMPL-306 Dose Level 3 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
7
11
6
11
10
11
EG003
Cohort 4: HMPL-306 Dose Level 4
Patients received HMPL-306 Dose Level 4 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
5
7
5
7
7
7
EG004
Cohort 5: HMPL-306 Dose Level 5
Patients received HMPL-306 Dose Level 5 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
5
6
5
6
6
6
EG005
Cohort 6: HMPL-306 Dose Level 6
Patients received HMPL-306 Dose Level 6 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
3
4
3
4
3
4
EG006
Cohort 7: HMPL-306 Dose Level 7
Patients received HMPL-306 Dose Level 7 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
2
4
4
4
3
4
EG007
Cohort 8: HMPL-306 Dose Level 8
Patients received HMPL-306 Dose Level 8 tablet orally once on Day 1 of the PK week (7 days prior to Cycle 1 Day 1) (applicable for dose escalation part) and then QD from Cycle 1 Day 1 until PD, death, intolerable toxicity, withdrawal of consent, lost to follow-up, meeting conditions for treatment discontinuation specified in protocol, or end of study, whichever came first. Each cycle duration was 28 days.
4
8
5
8
8
8
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0026 events3 affected11 at risk
EG0031 events1 affected7 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected4 at risk
EG0064 events2 affected4 at risk
EG0071 events1 affected8 at risk
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0052 events2 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Abdominal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Bacterial sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Escherichia bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Otitis externa
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Perirectal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pneumonia fungal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Respiratory tract infection fungal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Skin infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Soft tissue infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected11 at risk
EG0032 events2 affected7 at risk
EG0045 events2 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected8 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Disease progression
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0072 events2 affected8 at risk
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected8 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Differentiation syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
Encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Middle ear inflammation
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Cellulite
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Haematoma
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0042 events2 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Bacterial sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Bartholinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Cystitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Ear infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Fungal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Gastrointestinal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Oral herpes
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Otitis media
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pneumonia klebsiella
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected8 at risk
Rhinovirus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Skin infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Viral infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG00110 events3 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0042 events2 affected6 at risk
EG0051 events1 affected4 at risk
EG0062 events1 affected4 at risk
EG0074 events3 affected8 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0047 events2 affected6 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected4 at risk
EG0074 events2 affected8 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0063 events1 affected4 at risk
EG0077 events3 affected8 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Haemorrhagic diathesis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hyperleukocytosis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0044 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypofibrinogenaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0024 events2 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected4 at risk
EG0072 events1 affected8 at risk
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0005 events3 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Catheter site haemorrhage
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Decreased activity
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Gait disturbance
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Nodule
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Puncture site haemorrhage
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0033 events2 affected7 at risk
EG0044 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0073 events3 affected8 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Odynophagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Oral blood blister
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Toothache
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0042 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected8 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0047 events2 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0049 events2 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0044 events2 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0044 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG00112 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected8 at risk
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hepatic enzyme abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected8 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0046 events3 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0034 events2 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Nasal pruritus
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Anxiety
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
Adjustment disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Sleep disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Cranial nerve disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0072 events1 affected8 at risk
Facial nerve disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Presyncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0042 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Haematoma
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pallor
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Splinter
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Pericardial effusion
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Periorbital oedema
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Vision blurred
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Differentiation syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Thyroid mass
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Immunodeficiency
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
3
BG0053
BG0062
BG0074
BG00825
5
BG0053
BG0064
BG0075
BG00831
0
BG0050
BG0060
BG0070
BG0082
5
BG0054
BG0064
BG0077
BG00840
0
BG0050
BG0060
BG0070
BG0084
5
OG0043
OG0053
OG0063
OG0075
0
OG0040
OG0050
OG0060
OG0070
7
OG0046
OG0054
OG0064
OG0078
7
OG0046
OG0053
OG0064
OG0078
Any TESAE
Title
Measurements
OG0003
OG0011
OG0026
OG0035
OG0045
OG0053
OG0064
OG0075
5
OG0045
OG0054
OG0063
OG0078
1
OG0040
OG0050
OG0060
OG0071
CR
OG0000
OG0010
OG0023
OG0030
OG0040
OG0050
OG0061
OG0073
CRh
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0061
OG0070
CRi
OG0000
OG0010
OG0022
OG0030
OG0042
OG0050
OG0060
OG0071
MLFS
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
PR
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
SD
OG0001
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
PD
OG0000
OG0011
OG0023
OG0032
OG0042
OG0052
OG0061
OG0072
Not evaluable
OG0002
OG0012
OG0021
OG0031
OG0040
OG0051
OG0060
OG0071
5
OG0045
OG0054
OG0063
OG0078
50.0
(18.7 to 81.3)
OG00340.0(5.3 to 85.3)
OG00460.0(14.7 to 94.7)
OG0050(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable as there were no patients with CRmrd-, CR, CRh, CRi, MLFS or PR at study termination.
OG00666.7(9.4 to 99.2)
OG00762.5(24.5 to 91.5)
2
OG0043
OG0050
OG0062
OG0075
2.891
(2.07 to 3.71)
OG0071.87(1.84 to 1.87)
2
OG0043
OG0050
OG0062
OG0075
0.84
(0.69 to NA)
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0061.87(NA to NA)NA indicates that the upper and lower limits of 95% CI were not estimable, as there were insufficient numbers of patients with 1/2 patients censored prior to any event.
OG0073.71(1.87 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
5
OG0045
OG0054
OG0063
OG0078
60.0
(26.2 to 87.8)
OG00340.0(5.3 to 85.3)
OG00460.0(14.7 to 94.7)
OG00525.0(0.6 to 80.6)
OG00666.7(9.4 to 99.2)
OG00762.5(24.5 to 91.5)
5
OG0045
OG0054
OG0063
OG0078
5.08
(0.62 to NA)
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0037.39(3.22 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0044.57(2.10 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0053.71(1.87 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0065.55(0.79 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0074.62(0.49 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
5
OG0045
OG0054
OG0063
OG0078
13.01
(0.62 to NA)
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG00315.24(5.19 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0047.66(5.36 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0059.89(3.06 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0066.01(0.79 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG00713.47(0.49 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
5
OG0045
OG0054
OG0063
OG0078
0.03
(0.03 to 5.65)
OG0030.03(0.03 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0045.55(0.03 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0050.03(NA to NA)NA indicates that the upper and lower limits of 95% CI were not estimable, as all the patients in this cohort experienced an event of treatment failure at Day 1 (0.03 months).
OG0065.55(0.03 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0074.62(0.03 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
5
OG0045
OG0054
OG0063
OG0078
4
OG0044
OG0054
OG0063
OG0078
Post-baseline TI for >=8 weeks
Title
Measurements
OG0000
OG0010
OG0026
OG0032
OG0044
OG0051
OG0062
OG0076
7
OG0046
OG0054
OG0064
OG0078
7
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG000NA± NANA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
OG001NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
OG002NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
OG003NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
OG004NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
OG005NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
OG006NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
OG007NA± NANA indicates that mean and SD were not estimable as the values were below the LLOQ of 1.00 ng/mL.
PK Week: 0.5 hour post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0077
Title
Measurements
OG00040.6± 33.1
OG00112.8± 9.02
OG002155± 200
OG003
PK Week: 1 hour post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0045
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0077
Title
Measurements
OG000115± 67.5
OG001223± 161
OG002320± 256
OG003
PK Week: 2 hours post-dose on Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0045
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0077
Title
Measurements
OG000151± 80.5
OG001412± 260
OG002417± 140
OG003
PK Week: 3 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0045
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG000130± 39.5
OG001275± 103
OG002379± 109
OG003
PK Week: 4 hours post-dose on Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0045
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG00093.9± 8.70
OG001164± 64.8
OG002293± 126
OG003
PK Week: 6 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0078
Title
Measurements
OG00048.9± 20.6
OG001131± 26.5
OG002192± 76.5
OG003
PK Week: 8 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG00047.3± 21.2
OG001110± 32.6
OG002151± 45.6
OG003
PK Week: 24 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0077
Title
Measurements
OG00023.8± 2.15
OG00163.5± 27.0
OG00285.6± 20.6
OG003
PK Week: 48 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0076
Title
Measurements
OG00017.1± 1.00
OG00142.9± 23.7
OG00264.3± 14.2
OG003
PK Week: 72 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0077
Title
Measurements
OG00015.9± 3.29
OG00139.9± 15.8
OG00255.9± 16.1
OG003
PK Week: 96 hours post-dose on Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG00013.4± 1.02
OG00134.2± 14.9
OG00252.5± 15.0
OG003
PK Week: 120 hours post-dose on Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0045
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0076
Title
Measurements
OG00013.3± 1.56
OG00132.2± 14.6
OG00243.0± 13.2
OG003
PK Week: 144 hours post-dose on Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0076
Title
Measurements
OG00011.7± 0.424
OG00129.4± 12.9
OG00240.5± 14.0
OG003
PK Week: 168 hours post-dose on Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG00210
ParticipantsOG0035
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0076
Title
Measurements
OG0009.62± 0.679
OG00127.6± 20.9
OG00238.9± 14.8
OG003
Cycle 2 Day 1: Pre-dose
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG000134± NANA indicates that SD was not estimable for only 1 patient.
OG001501± 244
OG002765± 359
OG003
Cycle 2 Day 1: 0.5 h post-dose
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
Title
Measurements
OG000134± NANA indicates that SD was not estimable for only 1 patient.
OG001592± 404
OG002921± 458
OG003
Cycle 2 Day 1: 1 h post-dose
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
Title
Measurements
OG000218± NANA indicates that SD was not estimable for only 1 patient.
OG001666± 486
OG0021324± 611
OG003
Cycle 2 Day 1: 2 h post-dose
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG000293± NANA indicates that SD was not estimable for only 1 patient.
OG001755± 267
OG0021191± 501
OG003
Cycle 2 Day 1: 3 h post-dose
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0076
Title
Measurements
OG000282± NANA indicates that SD was not estimable for only 1 patient.
OG001738± 107
OG0021084± 551
OG003
Cycle 2 Day 1: 4 h post-dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG000253± 89.1
OG001573± 26.9
OG002999± 351
OG003
Cycle 2 Day 1: 6 h post-dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG000252± 114
OG001505± 96.9
OG002851± 298
OG003
Cycle 2 Day 1: 8 h post-dose
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG000276± 148
OG001592± 164
OG002813± 397
OG003
Cycle 2 Day 1: 24 h post-dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0076
Title
Measurements
OG000206± 96.2
OG001502± 160
OG002837± 317
OG003
7
OG0046
OG0054
OG0064
OG0078
7
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG000151± 33.7
OG001376± 71.8
OG002476± 36.6
OG003574± 44.2
OG004749± 76.5
OG0051095± 13.4
OG006865± 53.5
OG0071225± 45.0
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG000413± 51.7
OG001921± 30.2
OG0021239± 61.6
OG003
7
OG0046
OG0054
OG0064
OG0078
7
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG0001.98(0.950 to 2.92)
OG0011.93(1.83 to 3.00)
OG0021.98(0.933 to 3.00)
OG0031.92(1.02 to 3.00)
OG0042.00(1.00 to 3.00)
OG0053.00(2.23 to 4.00)
OG0063.06(2.10 to 6.00)
OG0072.09(1.00 to 6.05)
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG0002.38(2.10 to 2.67)
OG0012.43(1.03 to 2.98)
OG0021.00(1.00 to 4.00)
OG003
7
OG0046
OG0054
OG0064
OG0078
7
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0078
Title
Measurements
OG0001143± 34.8
OG0012625± 42.7
OG0023780± 23.8
OG0034811± 22.1
OG0046436± 58.0
OG0058368± 16.4
OG0067846± 36.3
OG00711211± 47.1
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG0005697± 52.3
OG00112904± 24.0
OG00219159± 53.6
OG003
7
OG0045
OG0054
OG0064
OG0078
82.67
± 14.21
OG00459.51± 61.62
OG00588.54± 11.11
OG00694.28± 4.82
OG00787.47± 13.23
40.5
± 66.0
OG004101± 59.6
OG00528.5± 41.9
OG00665.0± 80.9
OG007206± 266
249
± 278
OG004541± 292
OG005268± 285
OG006258± 171
OG007826± 545
535
± 254
OG004955± 772
OG005999± 112
OG006777± 559
OG007869± 524
498
± 209
OG004868± 853
OG005970± 229
OG006689± 241
OG007918± 539
379
± 114
OG004596± 525
OG005744± 316
OG006601± 220
OG007985± 703
248
± 71.5
OG004327± 164
OG005387± 85.8
OG006498± 227
OG007719± 529
204
± 72.5
OG004249± 191
OG005331± 73.7
OG006375± 111
OG007517± 257
113
± 21.9
OG004167± 76.8
OG005177± 55.6
OG006183± 56.6
OG007301± 148
79.2
± 18.4
OG004119± 49.7
OG005119± 22.9
OG006132± 51.9
OG007202± 106
66.3
± 12.8
OG00497.1± 48.1
OG005108± 19.9
OG006114± 48.4
OG007167± 76.1
61.2
± 11.7
OG00483.8± 38.8
OG00593.0± 15.3
OG00688.0± 48.8
OG007175± 84.6
52.9
± 4.73
OG00464.0± 25.9
OG00579.8± 13.1
OG00683.3± 38.9
OG007138± 73.4
47.2
± 4.18
OG00456.2± 28.1
OG00572.2± 3.68
OG00655.8± 26.2
OG007132± 71.8
46.2
± 8.64
OG00490.3± 24.9
OG00564.6± 8.62
OG00650.7± 22.7
OG007125± 68.4
765
± 110
OG004916± 573
OG0051558± 637
OG0061475± 247
OG0072133± 978
871
± 300
OG0041622± 1510
OG0051632± 700
OG0061585± 318
OG0072616± 972
1063
± 319
OG0041930± 1273
OG0052167± 981
OG0062250± 170
OG0072776± 1066
1208
± 363
OG0041910± 1075
OG0052310± 919
OG0062250± 594
OG0073372± 948
1227
± 239
OG0041730± 891
OG0052213± 419
OG0061630± NANA indicates that SD was not estimable for only 1 patient.
OG0072887± 1194
946
± 125
OG0041180± 608
OG0051873± 597
OG0061695± 530
OG0072345± 775
870
± 125
OG0041082± 493
OG0051697± 431
OG0061445± 403
OG0072242± 910
829
± 27.0
OG004970± 523
OG0051770± 502
OG0061640± 636
OG0072170± 972
746
± 96.8
OG004899± 553
OG0051484± 488
OG0061230± NANA indicates that SD was not estimable for only 1 patient.