Study of FF-10502-01 in Patients With Advanced Solid Tumo... | NCT02661542 | Trialant
NCT02661542
Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.
Status
Completed
Last Update Posted
Apr 23, 2026Actual
Enrollment
106Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors
Lymphomas
Interventions
FF-10502-01
Countries
United States
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
NCT02661542
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FF1050201US101
Secondary IDs
Not provided
Brief Title
Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas
Official Title
A Phase 1/2a, Dose-escalation Study of FF-10502-01 for the Treatment of Advanced Solid Tumors and Lymphomas
Acronym
Not provided
Organization
Fujifilm Pharmaceuticals U.S.A., Inc.INDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2016Actual
Primary Completion Date
Nov 5, 2020Actual
Completion Date
Nov 5, 2020Actual
First Submitted Date
Jan 13, 2016
First Submission Date that Met QC Criteria
Jan 19, 2016
First Posted Date
Jan 22, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 8, 2025
Results First Submitted that Met QC Criteria
Apr 21, 2026
Results First Posted Date
Apr 23, 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
Apr 21, 2026
Last Update Posted Date
Apr 23, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.INDUSTRY
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
A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD). Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Cohort 2 will include subjects with another tumor type enrolled in the Phase 1 dose-escalation phase who have demonstrated Clinical Benefit by Week 16.
Detailed Description
Subjects will receive doses of FF-10502-01 intravenously (IV) weekly for three weeks, repeated every 28 days (= 1 cycle). Disease assessments, based on computed tomography (CT), magnetic resonance image (MRI), and, for lymphoma, [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) scans, will be obtained at Week 8 and every 8 weeks thereafter until documented progression of disease (PD). Subjects who demonstrate clinical benefit will be allowed to continue therapy with FF-10502-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Conditions Module
Conditions
Solid Tumors
Lymphomas
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
106Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1, Cohorts 1-9
Experimental
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing by cohort: Cohort 1, 8mg/m2; Cohort 2, 12mg/m2; Cohort 3, 18mg/m2, Cohort 4, 27mg/m2; Cohort 5, 40mg/m2; Cohort 6, 60mg/m2; Cohort 7, 90mg/m2; Cohort 8, 135mg/m2; Cohort 9, 100mg/m2.
Drug: FF-10502-01
Phase 2a, Cohort 10, Advanced solid tumors
Experimental
FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Drug: FF-10502-01
Phase 2a, Cohort 11, Cholangiocarcinoma
Experimental
FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Drug: FF-10502-01
Phase 2a, Cohort 12, Gall bladder carcinoma
Experimental
FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Drug: FF-10502-01
Phase 2a, Cohort 13, Urothelial carcinoma
Experimental
FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FF-10502-01
Drug
Phase 1, Cohorts 1-9
Phase 2a, Cohort 10, Advanced solid tumors
Phase 2a, Cohort 11, Cholangiocarcinoma
Phase 2a, Cohort 12, Gall bladder carcinoma
Phase 2a, Cohort 13, Urothelial carcinoma
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)
Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Overall Response Rates (ORR)
Number of subjects who had overall responses of Partial Response, Stable Disease, Progressive Disease or Not Evaluable
Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 18 years of age
Histologically or cytologically confirmed advanced or metastatic solid tumor or l lymphoma, that is refractory to standard therapy, relapsed after standard therapy, or for which no standard therapy available that is expected to improve survival by at least three months
At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
Life expectancy of ≥ 3 months
Adequate hematologic parameters without ongoing transfusional support:
Hemoglobin (Hb) ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1.0 x 109 cells/L
Platelets ≥ 100 x 109 cells/L
Adequate renal and hepatic function:
Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ( ≤ 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
QT interval corrected for rate (QTc) ≤ 480 msec on the electrocardiogram (ECG) obtained at Screening
Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.
Ability to provide written informed consent
Exclusion Criteria:
Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior or currently treated brain metastases are allowed.
Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
Pregnant or breast-feeding
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
Filip Janku, MD
University of Texas MD Anderson Center
Principal Investigator
Gerald Falchook, MD
Sarah Cannon Research Institute-Denver
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sarah Cannon Research Institute at HealthOne
Denver
Colorado
80218
United States
University of Texas MD Anderson Cancer Center
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
For Phase 1, anticipated enrollment was 40 subjects; 40 subjects were enrolled and treated with FF-10501-01.
For Phase 2, anticipated enrollment was 66 subjects; 66 were enrolled and treated with FF-10501-01.
Recruitment Details
Participants were recruited based on physician referral at 2 academic medical centers between January 2016 and November 2020. The first participant was dosed on January 14, 2016 and the last participant was dosed on October 3, 2020. Study completion date was November 5, 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FG001
Phase 1 Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
FG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
FG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
FG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0047 subjects
FG0053 subjects
FG0069 subjects
FG0076 subjects
FG0083 subjects
FG00919 subjects
FG01036 subjects
FG01110 subjects
FG0121 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
BG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
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
Median
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
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)
Safety Analysis Population
Posted
Number
participants
Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
Adverse Events Module
Frequency Threshold
5
Time Frame
Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Description
Definitions of AE and/or SAEs are the same as defined above
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
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
chest pain
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
fatigue
General disorders
MedDRA 15.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Vice President of Clinical Operations and Development
Number of Subjects With Objective Response (OR) Events
Number of subjects with objective response events, number of subjects with progressive disease or death events atter objective response and number of subjects censored after objective response
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Objective Response (OR)
Median duration of objective response in days for each cohort".
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Stable Disease (SD) Events
Number of subjects with stable disease, number of subjects with progressive disease or death after stable disease and number of subjects censored after stable disease
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Stable Disease (SD)
Median duration of stable disease (SD) in days for each cohort
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Progression-free Survival (PFS) Events
Number of subjects with progressive disease or death and number of subject censored.
Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Progression-free Survival (PFS)
This outcome measure shows the median number of days of progression-free survival (PFS) for each cohort
Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Overall Survival (OS) Events
Number of subjects with overall survival (OS) events in each cohort
Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Overall Survival (OS)
Median number of days of overall survival (OS) for each cohort
Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Houston
Texas
77030
United States
7 subjects
FG0053 subjects
FG0069 subjects
FG0076 subjects
FG0083 subjects
FG00919 subjects
FG01036 subjects
FG01110 subjects
FG0121 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
BG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
BG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
BG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
BG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
BG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
BG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
BG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
BG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
BG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
BG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
BG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
BG013
Total
Total of all reporting groups
3
BG0013
BG0023
BG0033
BG0047
BG0053
BG0069
BG0076
BG0083
BG00919
BG01036
BG01110
BG0121
BG013106
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00059(56 to 63)
BG00165(63 to 80)
BG00267(50 to 67)
BG00363(48 to 78)
BG00467(21 to 74)
BG00565(61 to 68)
BG00661(48 to 72)
BG00743(38 to 73)
BG00862(38 to 73)
BG00966(38 to 84)
BG01059(33 to 83)
BG01164(45 to 75)
BG01259(59 to 59)
BG01362(21 to 84)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG0022
BG0030
BG0043
BG0053
BG0064
BG0073
BG0082
BG0099
BG01023
BG0117
BG0121
BG01360
Male
BG0001
BG0012
BG0021
BG0033
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0020
BG0030
BG0041
BG0050
BG0060
BG0072
BG0080
BG0092
BG0105
BG0110
BG0120
BG01311
Not Hispanic or Latino
BG0003
BG0012
BG0023
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0131
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0003
BG0013
BG0023
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2 FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2 FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
Title
Denominators
Categories
Any Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0003
OG0013
OG0023
OG0033
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0120
Any dose limiting toxicity (DLT)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Study drug-related Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0003
OG0013
OG0023
OG003
Serious Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0002
OG0010
OG0022
OG003
Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0002
OG0011
OG0022
OG003
Grade 3 or 4 drug-related Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Discontinuations due to Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Interruptions due to Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0001
OG0011
OG0022
OG003
Death due to Treatment Emergent Adverse Events (TEAEs)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Subjects With Overall Response Rates (ORR)
Number of subjects who had overall responses of Partial Response, Stable Disease, Progressive Disease or Not Evaluable
Full Analysis Set Population
Posted
Number
participants
Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Partial Response
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Number of Subjects With Objective Response (OR) Events
Number of subjects with objective response events, number of subjects with progressive disease or death events atter objective response and number of subjects censored after objective response
Posted
Number
participants
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2 FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Number of Subjects with Objective Response events
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Median Number of Days of Objective Response (OR)
Median duration of objective response in days for each cohort".
Posted
Median
90% Confidence Interval
days
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2 FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG001NA(NA to NA)0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG002
Secondary
Number of Subjects With Stable Disease (SD) Events
Number of subjects with stable disease, number of subjects with progressive disease or death after stable disease and number of subjects censored after stable disease
Full Analysis Set Population
Posted
Number
participants
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2100mg/m2.
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 2, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2 FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Number of Subjects with Stable Disease Events
Title
Measurements
OG0001
OG0011
OG0021
OG003
Secondary
Median Number of Days of Stable Disease (SD)
Median duration of stable disease (SD) in days for each cohort
Full Analysis Set Population
Posted
Median
90% Confidence Interval
days
Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2100mg/m2.
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2 FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000589(NA to NA)1 out of 2 evaluable patients (total n=3) had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
OG001288(NA to NA)1 out of 3 patients had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
OG002
Secondary
Number of Subjects With Progression-free Survival (PFS) Events
Number of subjects with progressive disease or death and number of subject censored.
Full Analysis Set Population
Posted
Number
participants
Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2 FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Number of Patients with Disease Progression or Death Events
Title
Measurements
OG0002
OG0013
OG0023
OG003
Secondary
Median Number of Days of Progression-free Survival (PFS)
This outcome measure shows the median number of days of progression-free survival (PFS) for each cohort
Full Analysis Set Population
Posted
Median
90% Confidence Interval
days
Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2 FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000642(27 to NA)2 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00153(53 to NA)3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG002
Secondary
Number of Subjects With Overall Survival (OS) Events
Number of subjects with overall survival (OS) events in each cohort
Full Analysis Set Population
Posted
Number
participants
Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Number of Subjects with Death Events
Title
Measurements
OG0000
OG0012
OG0022
OG003
Secondary
Median Number of Days of Overall Survival (OS)
Median number of days of overall survival (OS) for each cohort
Full Analysis Set Population
Posted
Median
90% Confidence Interval
days
Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
ID
Title
Description
OG000
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
OG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
OG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
OG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
OG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
OG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
OG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
OG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
OG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
OG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
OG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
OG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
OG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)0 out of 3 patients had a death event; 3 patients were censored
OG001157(115 to NA)2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
OG002
0
3
2
3
3
3
EG001
Phase 1, Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
2
3
0
3
3
3
EG002
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
2
3
2
3
3
3
EG003
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
2
3
2
3
3
3
EG004
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
1
7
5
7
7
7
EG005
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
2
3
0
3
3
3
EG006
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
5
9
5
9
9
9
EG007
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
0
6
5
6
6
6
EG008
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
3
3
0
3
3
3
EG009
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
14
19
14
19
19
19
EG010
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
15
36
20
36
36
36
EG011
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
1
10
2
10
10
10
EG012
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
1
1
0
1
1
1
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
cholesystitis
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
ascites
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
blood bilirubin increased
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0105 events4 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
nausea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected1 at risk
vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0112 events1 affected10 at risk
EG0120 events0 affected1 at risk
small intestinal obstruction
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
vaginal hemorrhage
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
anemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0105 events4 affected36 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected1 at risk
pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
blood creatinine increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
hemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
hypersensitivity
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
pneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0095 events5 affected19 at risk
EG0102 events2 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
pharyngeal hemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
blood sodium increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
hypotension
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
gastrointestinal hemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
fatigue
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected19 at risk
EG0102 events2 affected36 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected1 at risk
transient ischemic attack
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
alanine aminotransferase increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
aspartate aminotransferase increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
bile duct obstruction
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
transfusion reaction
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
abdominal distention
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
diplopia
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
cholangitis
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0105 events3 affected36 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected1 at risk
enterobacter sepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected1 at risk
liver abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
sepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
colitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
blood glucose decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
influenza
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
lung infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
anemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0101 events1 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected1 at risk
EG0003 affected3 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG0033 events3 affected3 at risk
EG0043 affected7 at risk
EG0052 affected3 at risk
EG0065 affected9 at risk
EG0073 affected6 at risk
EG0081 affected3 at risk
EG0099 affected19 at risk
EG01019 affected36 at risk
EG0115 affected10 at risk
EG0120 affected1 at risk
pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0043 affected7 at risk
EG0051 affected3 at risk
EG0064 affected9 at risk
EG0075 affected6 at risk
EG0081 affected3 at risk
EG0095 affected19 at risk
EG01014 affected36 at risk
EG0113 affected10 at risk
EG0121 affected1 at risk
mucosal inflammation
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected7 at risk
EG0052 affected3 at risk
EG0061 affected9 at risk
EG0070 affected6 at risk
EG0081 affected3 at risk
EG0091 affected19 at risk
EG01011 affected36 at risk
EG0111 affected10 at risk
EG0121 affected1 at risk
chills
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected7 at risk
EG0052 affected3 at risk
EG0061 affected9 at risk
EG0073 affected6 at risk
EG0080 affected3 at risk
EG0092 affected19 at risk
EG0106 affected36 at risk
EG0110 affected10 at risk
EG0120 affected1 at risk
nausea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0032 affected3 at risk
EG0045 affected7 at risk
EG0052 affected3 at risk
EG0061 affected9 at risk
EG0071 affected6 at risk
EG0081 affected3 at risk
EG0094 affected19 at risk
EG01013 affected36 at risk
EG0113 affected10 at risk
EG0120 affected1 at risk
constipation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG0031 affected3 at risk
EG0041 affected7 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0071 affected6 at risk
EG0081 affected3 at risk
EG0094 affected19 at risk
EG0109 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
diarrhea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0041 affected7 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0071 affected6 at risk
EG0080 affected3 at risk
EG0093 affected19 at risk
EG0109 affected36 at risk
EG0114 affected10 at risk
EG0120 affected1 at risk
vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0043 affected7 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected6 at risk
EG0081 affected3 at risk
EG0094 affected19 at risk
EG01012 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0042 affected7 at risk
EG0052 affected3 at risk
EG0060 affected9 at risk
EG0071 affected6 at risk
EG0080 affected3 at risk
EG0096 affected19 at risk
EG0108 affected36 at risk
EG0113 affected10 at risk
EG0120 affected1 at risk
pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0042 affected7 at risk
EG0052 affected3 at risk
EG0063 affected9 at risk
EG0075 affected6 at risk
EG0081 affected3 at risk
EG0096 affected19 at risk
EG01013 affected36 at risk
EG0111 affected10 at risk
EG0121 affected1 at risk
rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG0031 affected3 at risk
EG0043 affected7 at risk
EG0052 affected3 at risk
EG0063 affected9 at risk
EG0072 affected6 at risk
EG0080 affected3 at risk
EG0091 affected19 at risk
EG01015 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
dry skin
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected7 at risk
EG0051 affected3 at risk
EG0064 affected9 at risk
EG0071 affected6 at risk
EG0080 affected3 at risk
EG0093 affected19 at risk
EG0108 affected36 at risk
EG0115 affected10 at risk
EG0120 affected1 at risk
blood potassium decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0041 affected7 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0072 affected6 at risk
EG0081 affected3 at risk
EG0092 affected19 at risk
EG0107 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
aspartate aminotransferase increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0040 affected7 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0072 affected6 at risk
EG0080 affected3 at risk
EG0091 affected19 at risk
EG0104 affected36 at risk
EG0111 affected10 at risk
EG0120 affected1 at risk
dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0043 affected7 at risk
EG0052 affected3 at risk
EG0064 affected9 at risk
EG0073 affected6 at risk
EG0080 affected3 at risk
EG0096 affected19 at risk
EG0105 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0042 affected7 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0070 affected6 at risk
EG0081 affected3 at risk
EG0091 affected19 at risk
EG0104 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
headache
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected7 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0072 affected6 at risk
EG0080 affected3 at risk
EG0091 affected19 at risk
EG0101 affected36 at risk
EG0110 affected10 at risk
EG0120 affected1 at risk
dizziness
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0042 affected7 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0071 affected6 at risk
EG0081 affected3 at risk
EG0090 affected19 at risk
EG0102 affected36 at risk
EG0111 affected10 at risk
EG0120 affected1 at risk
neuropathy peripheral
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0032 affected3 at risk
EG0041 affected7 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected6 at risk
EG0080 affected3 at risk
EG0091 affected19 at risk
EG0103 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
anemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0043 affected7 at risk
EG0052 affected3 at risk
EG0062 affected9 at risk
EG0072 affected6 at risk
EG0083 affected3 at risk
EG0096 affected19 at risk
EG0109 affected36 at risk
EG0114 affected10 at risk
EG0120 affected1 at risk
thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected7 at risk
EG0053 affected3 at risk
EG0063 affected9 at risk
EG0070 affected6 at risk
EG0080 affected3 at risk
EG0095 affected19 at risk
EG01021 affected36 at risk
EG0111 affected10 at risk
EG0120 affected1 at risk
decreased appetite
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0032 affected3 at risk
EG0040 affected7 at risk
EG0052 affected3 at risk
EG0062 affected9 at risk
EG0070 affected6 at risk
EG0081 affected3 at risk
EG0098 affected19 at risk
EG01014 affected36 at risk
EG0113 affected10 at risk
EG0120 affected1 at risk
blood bilirubin increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected7 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected6 at risk
EG0080 affected3 at risk
EG0092 affected19 at risk
EG0106 affected36 at risk
EG0112 affected10 at risk
EG0120 affected1 at risk
skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected7 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0073 affected6 at risk
EG0080 affected3 at risk
EG0092 affected19 at risk
EG01011 affected36 at risk
EG0111 affected10 at risk
EG0121 affected1 at risk
oral herpes
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected7 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected6 at risk
EG0081 affected3 at risk
EG0090 affected19 at risk
EG0100 affected36 at risk
EG0110 affected10 at risk
EG0121 affected1 at risk
confusional state
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected7 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected6 at risk
EG0080 affected3 at risk
EG0090 affected19 at risk
EG0100 affected36 at risk
EG0110 affected10 at risk
EG0121 affected1 at risk
international normalized ratio (INR) increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected7 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected6 at risk
EG0080 affected3 at risk
EG0090 affected19 at risk
EG0100 affected36 at risk
EG0110 affected10 at risk
EG0121 affected1 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D006425
Hemic and Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
4
BG0050
BG0065
BG0073
BG0081
BG00910
BG01013
BG0113
BG0120
BG01346
6
BG0053
BG0069
BG0074
BG0083
BG00917
BG01030
BG0119
BG0121
BG01393
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0111
BG0120
BG0132
0
BG0050
BG0061
BG0071
BG0080
BG0091
BG0103
BG0110
BG0120
BG0136
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
0
BG0050
BG0060
BG0070
BG0081
BG0091
BG0101
BG0110
BG0120
BG0133
7
BG0053
BG0067
BG0075
BG0082
BG00916
BG01027
BG01110
BG0121
BG01390
0
BG0050
BG0060
BG0070
BG0080
BG0091
BG0102
BG0110
BG0120
BG0133
0
BG0050
BG0061
BG0070
BG0080
BG0090
BG0102
BG0110
BG0120
BG0133
0
OG0041
OG0050
OG0060
OG0072
OG0082
OG0090
OG0100
OG0110
OG0120
2
OG0047
OG0053
OG0068
OG0075
OG0083
OG00914
OG01036
OG01110
OG0120
2
OG0045
OG0050
OG0065
OG0075
OG0080
OG00914
OG01020
OG0112
OG0120
2
OG0044
OG0052
OG0065
OG0075
OG0081
OG00917
OG01020
OG0115
OG0120
0
OG0041
OG0050
OG0063
OG0072
OG0081
OG0096
OG0106
OG0112
OG0120
1
OG0040
OG0050
OG0061
OG0070
OG0080
OG0094
OG0105
OG0111
OG0120
0
OG0043
OG0052
OG0063
OG0075
OG0081
OG0095
OG01015
OG0115
OG0120
1
OG0040
OG0050
OG0061
OG0070
OG0080
OG0092
OG0102
OG0111
OG0120
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
0
OG0041
OG0051
OG0060
OG0071
OG0080
OG0090
OG0101
OG0111
OG0120
Stable Disease
Title
Measurements
OG0002
OG0011
OG0020
OG0031
OG0041
OG0051
OG0064
OG0074
OG0080
OG0098
OG01021
OG0113
OG0121
Progressive Disease
Title
Measurements
OG0001
OG0012
OG0022
OG0030
OG0042
OG0050
OG0063
OG0070
OG0083
OG0098
OG01010
OG0116
OG0120
Not Evaluable
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0043
OG0051
OG0062
OG0071
OG0080
OG0093
OG0104
OG0110
OG0120
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
0
OG0041
OG0051
OG0060
OG0071
OG0080
OG0090
OG0101
OG0111
OG0120
Number of Subjects with Progressive Disease or death after Objective Response
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0060
OG0071
OG0080
OG0090
OG0101
OG0111
OG0120
Number of Subjects Censored after Objective Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
30
(NA to NA)
1 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG003NA(NA to NA)0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG004206(NA to NA)1 out of 7 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG005115(NA to NA)1 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG006NA(NA to NA)0 out of 9 patients had an objective response, therefore the median and 95% confidence interval could not be calculated event
OG007204(NA to NA)1 out of 6 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG008NA(NA to NA)0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG009NA(NA to NA)0 out of 19 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG010130(NA to NA)1 out of 36 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG01168(NA to NA)1 out of 10 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
OG01222(NA to NA)0 out of 1 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
1
OG0042
OG0051
OG0063
OG0074
OG0080
OG0098
OG01022
OG0114
OG0121
Number of Subjects with Progressive Disease or Death after Stable Disease
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0042
OG0051
OG0063
OG0074
OG0080
OG0096
OG01012
OG0112
OG0121
Number of Subjects Censored after Stable Disease
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0071
OG0080
OG0092
OG01010
OG0112
OG0120
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
30
(NA to NA)
1 out of 3 patients had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
OG003281(NA to NA)1 out of 3 patients had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
OG004159(57 to NA)2 out of 7 patients had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
OG005NA(115 to NA)1 out of 3 patients had a stable disease event, therefore the median and 95% confidence interval could not be calculated
OG006136(11 to NA)3 out of 4 evaluable patients (total n=9) had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
OG007152(27 to NA)4 out of 5 evaluable patients (total n=6) had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
OG008NA(NA to NA)0 out of 3 patients had a stable disease event, therefore the median and 95% confidence interval could not be calculated
OG00928(11 to NA)8 out of 19 patients had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
OG010220(113 to 376)
OG011173(41 to NA)4 out of 10 patients had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
OG01222(22 to 22)
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
3
OG0045
OG0052
OG0067
OG0074
OG0083
OG00915
OG01024
OG0118
OG0121
Number of Patients Censored
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0042
OG0051
OG0062
OG0072
OG0080
OG0094
OG01012
OG0112
OG0120
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
56
(43 to NA)
3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00342(32 to NA)3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00452(29 to NA)5 out of 7 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG005243(168 to NA)2 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00657(54 to NA)7 out of 9 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG007258(53 to NA)4 out of 6 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00829(25 to NA)3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00955(37 to 57)
OG010146(58 to 240)
OG01156(29 to 96)
OG01222(22 to 22)
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
2
OG0041
OG0052
OG0065
OG0070
OG0083
OG00914
OG01015
OG0111
OG0121
Number of Subjects Censored
Title
Measurements
OG0003
OG0011
OG0021
OG0031
OG0046
OG0051
OG0064
OG0076
OG0080
OG0095
OG01021
OG0119
OG0120
3
OG0047
OG0053
OG0069
OG0076
OG0083
OG00919
OG01036
OG01110
OG0121
145
(61 to NA)
2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00342(32 to NA)2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
OG004NA(48 to NA)1 out of 7 patients had a death event; 6 patients were censored. There was an insufficient number of events to calculate the upper 95% confidence interval
OG005243(210 to NA)2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
OG006113(58 to NA)5 out of 9 patients had a death event; 4 patients were censored. There was an insufficient number of events to calculate the upper 95% confidence interval
OG007NA(NA to NA)0 out of 6 patients had a death event; 6 patients were censored
OG00897(63 to NA)3 out of 3 patients had a death event. There was an insufficient number of events to calculate the upper 95% confidence interval
OG00970(43 to 124)
OG010274(163 to NA)15 out of 36 patients had a death event; 21 patients were censored. There was an insufficient number of events to calculate the upper 95% confidence interval