FGF401 in HCC and Solid Tumors Characterized by Positive... | NCT02325739 | Trialant
NCT02325739
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Oct 21, 2024Actual
Enrollment
172Actual
Phase
Phase 1Phase 2
Conditions
Hepatocellular Carcinoma (HCC)
Solid Malignancies
Interventions
FGF401
PDR001
Countries
United States
China
France
Germany
Hong Kong
Italy
Japan
Singapore
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02325739
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CFGF401X2101
Secondary IDs
ID
Type
Description
Link
2014-002929-35
EudraCT Number
Brief Title
FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression
Official Title
A Phase I/II, Multicenter, Open-label Study of Oral FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB Expression
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 29, 2014Actual
Primary Completion Date
May 30, 2019Actual
Completion Date
May 30, 2019Actual
First Submitted Date
Dec 9, 2014
First Submission Date that Met QC Criteria
Dec 24, 2014
First Posted Date
Dec 25, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 29, 2020
Results First Submitted that Met QC Criteria
Nov 21, 2020
Results First Posted Date
Dec 17, 2020Actual
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
Sep 30, 2024
Last Update Posted Date
Oct 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
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
Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.
Detailed Description
The primary objectives of this study were in 2 parts: Phase l & Phase II.
The study included different periods starting by molecular pre-screening (applicable for all subjects enrolled under protocol versions 00 to 03, or applicable only for Phase I and Group 3 in Phase II of FGF401 single agent, for subjects enrolled under protocol version 04), Screening, Treatment, End of Treatment, Disease progression follow-up (if applicable), Safety follow-up and then ended by survival follow-up period
In the Phase I part, subjects with HCC or other advanced solid tumors characterized by positive FGFR4 and KLB expression were enrolled and treated with FGF401 as a single agent or in combination with PDR001. Subjects in this phase were dosed under fasted or fed conditions.
In the Phase 2 part, subjects with advanced HCC or other solid tumors bearing positive FGFR4 and KLB expression were enrolled into three groups (Group 1: HCC subjects from Asian countries; Group 2: HCC subjects from non-Asian countries; Group 3: Subjects with other solid malignancies regardless of geography) to assess the preliminary anti-tumor activity of FGF401 in Phase ll. This Phase II part investigated the anti-tumor activity of FGF401 single agent and in combination with PDR001.
Each group within the Phase II dose expansion part targeted a different number of subjects. Group 1 and Group 2 planned to enroll around 40 subjects each and Group 3 planned to enroll approximately 20 subjects. Subjects in this phase were dosed under fasted conditions.
Oral FGF401 was administered on a continuous once daily (QD) dosing regimen for both FGF401 single agent and in combination with PDR001 parts. Intravenous PDR001 was administered in a fixed dosing regimen of 300 mg iv every three weeks as per protocol until subject experienced unacceptable toxicity, progressive disease and/or treatment was discontinued at the discretion of the Investigator or withdrawal of consent.
Because the enrollment of new subjects in this study was halted for business reason on 03-Jul-2018 early enrollment termination was declared following the initial halt of enrollment once the global last subject last visit was achieved as per protocol, and consequently the phase II part of the FGF401+PDR001 combination did not start, none of the planned analyses related to the phase II part of the FGF401+PDR001 combination arm were performed.
Duration of treatment: Subjects could continue study treatment until they experienced any of the following: Disease progression (radiologically documented according to RECIST v1.1) as assessed by the Investigator, unacceptable toxicity, & treatment was discontinued at the discretion of the Investigator or the subject.
Subjects who permanently discontinued the study treatment for any reason other than disease progression or withdrawal of consent had to continue efficacy assessments as scheduled in the protocol until the time of disease progression.
Conditions Module
Conditions
Hepatocellular Carcinoma (HCC)
Solid Malignancies
Keywords
FGF401
PDR001
PD-1
FGFR4
FGF19
HCC
solid malignancies characterized by positive FGFR4 and KLB expression
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
172Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase I: FGF401 50 mg fasted
Experimental
Participants received single agent FGF401 50 mg while fasted
Drug: FGF401
Phase I: FGF401 80 mg fasted
Experimental
Participants received single agent FGF401 80 mg while fasted
Drug: FGF401
Phase I: FGF401 80 mg fed
Experimental
Participants received single agent FGF401 80 mg while fed
Drug: FGF401
Phase I: FGF401 120 mg fasted
Experimental
Participants received single agent FGF401 120 mg while fasted
Drug: FGF401
Phase I: FGF401 120 mg fed
Experimental
Participants received single agent FGF401 120 mg while fed
Drug: FGF401
Phase I: FGF401 150 mg fasted
Experimental
Participants received single agent FGF401 150 mg while fasted
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FGF401
Drug
FGF401 is a FGFR4 inhibitor.
Phase I: FGF401 120 mg + PDR001 300 mg
Phase I: FGF401 120 mg fasted
Phase I: FGF401 120 mg fed
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicity (DLT): Phase I Only
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining set (DDS). A subject with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. A subject with multiple DLTs within a primary system organ class is counted only once in the total row.
Cycle 1 (C1) (21 days) for FGF401 single agent, Cycle 1 and Cycle 2 (C2) (42 days) for FGF401 and PDR001 combination
Time to Progression (TTP): Group 1 & Group 2 (Phase II Only)
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis.
Group 1: HCC subjects form Asian countries; Group 2: HCC subjects form non-Asian countries
approx. 4.5 years
Overall Response Rate (ORR) Based on Local Assessment: Group 3 (Phase II Only)
ORR is defined as the percentage of patients with a best overall response of CR or PR (RECIST v1.1).
FGF401 single agent-Phase II part - Group 3 (non-HCC, other solid tumors).
approx. 4.5 years
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
BOR is the best response recorded from the start of the treatment until disease progression/recurrence. BOR is determined according to: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and unknown.
approx. 4.5 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
ECOG Performance Status ≤ 1
Presence of at least one measurable lesion according to RECIST v1.1. c-i) FGF401 single agent-Phase I and Phase II, Group 3: Patients with HCC or advanced solid tumors, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists. c-ii) FGF401 single agent-Phase II, Groups 1 and 2: HCC patients previously treated with sorafenib for advanced HCC with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment c-iii) FGF401 in combination with PDR001:Advanced HCC patients who have received up to 2 previous lines of systemic treatment and one treatment must have included sorafenib with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment
Exclusion Criteria:
Previous treatment with a selective FGF19-FGFR4 targeted therapy and/or pan-FGFR inhibitor.
Symptomatic CNS metastases which are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.
Patient having out of range laboratory values defined as:
Chan SL, Schuler M, Kang YK, Yen CJ, Edeline J, Choo SP, Lin CC, Okusaka T, Weiss KH, Macarulla T, Cattan S, Blanc JF, Lee KH, Maur M, Pant S, Kudo M, Assenat E, Zhu AX, Yau T, Lim HY, Bruix J, Geier A, Guillen-Ponce C, Fasolo A, Finn RS, Fan J, Vogel A, Qin S, Riester M, Katsanou V, Chaudhari M, Kakizume T, Gu Y, Porta DG, Myers A, Delord JP. A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors. J Exp Clin Cancer Res. 2022 Jun 2;41(1):189. doi: 10.1186/s13046-022-02383-5.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
At least 21 evaluable subjects were to be treated in Phase I for the model to have reasonable operating characteristics relating to its MTD &/or RP2D. Each group in the Phase II dose expansion targeted a different number of subjects. Group 1 & Group 2 planned to enroll around 40 subjects each & Group 3 planned to enroll approximately 20 subjects.
Recruitment Details
160 subjects were enrolled & treated with FGF401 single agent. In the Phase I part 74 subjects & 86 subjects in the Phase II part. 12 subjects were treated in the Phase I of the combination of FGF401 and PDR001. All subjects completed the study as per protocol & reasons for discontinuation of treatment are provided in the 'Not Completed' section.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
FG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
Periods
Title
Milestones
Reasons Not Completed
Phase I Part
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 27, 2018
May 29, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
Experimental
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
Drug: FGF401
Biological: PDR001
Phase I: FGF401 120 mg + PDR001 300 mg
Experimental
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Drug: FGF401
Biological: PDR001
Phase II: Group 1 - FGF401 120 mg QD
Experimental
Group 1 was comprised of HCC participants from Asian countries who received single agent FGF401 120 mg QD while fasted
Drug: FGF401
Phase II: Group 2 - FGF401 120 mg QD
Experimental
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
Drug: FGF401
Phase II: Group 3 - FGF401 120 mg QD
Experimental
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Drug: FGF401
Phase I: FGF401 150 mg fasted
Phase I: FGF401 50 mg fasted
Phase I: FGF401 80 mg + PDR001 300 mg
Phase I: FGF401 80 mg fasted
Phase I: FGF401 80 mg fed
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
PDR001
Biological
PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2
Phase I: FGF401 120 mg + PDR001 300 mg
Phase I: FGF401 80 mg + PDR001 300 mg
Overall Response Rate (ORR) by Investigator Assessment Phase I and FGF401 Single Agent Phase II Groups 1 & 2
ORR is defined as the proportion of patients with a best overall response of CR or PR (RECIST v1.1).
Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians)
approx. 4.5 years
Disease Control Rate (DCR) by Local Investigator Assessment Phase I and FGF401 Single Agent Phase II Groups 1, 2 & 3
DCR is the percentage of participants with a best overall response of CR or PR or SD per local assessment according to RECIST v1.1. Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians) and Group 3 (non-HCC, other solid tumors).
approx. 4.5 years
Time to Progression (TTP) in Participants Dosed With Single Agent FGF401 120 mg (Fasted & Fed) & With Combination FGF401 120 mg + PDR001 300 mg Q3W (Phase I)
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis.
approx. 4.5 years
Overall Survival (OS) in Participants Dosed With Single Agent FGF401 120 mg (Fasted & Fed) and in Participants Dosed With Combination FGF401 120 mg and PDR001 300 mg Q3W (Phase I & II)
Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. Method used was Kaplan-Meier analysis.
start of treatment to death, up to about 53 months
Progression-free Survival (PFS) - FGF401 Single Agent Phase II: Group 3
Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Group 3 - non-HCC, other solid tumors. Method used was Kaplan-Meier analysis.
4.5 years
Presence and/or Concentration of Anti-PDR001 Antibodies
Serum PDR001 concentrations as well as immunogenicity analysis were performed for all subjects receiving PDR001. Treatment-induced ADA-positive percentage was based on percentage subjects ADA-negative at baseline. Treatment-boosted ADA-positive percentage was based on subjects ADA-positive at baseline.
Day 1 of Cycle 1 to 6, approx. 10 months after C1D1 and 150-day safety follow up (FU)
Cmax of PDR001 in Combination With FGF401: Phase I
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
AUClast and AUCtau of PDR001 in Combination of FGF401: Phase I
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1)
AUCtau (AUC0 504h): The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
T1/2 of PDR001: Phase I
Due to the sparse PK sampling designed from PDR001, the PDR001 concentration data was insufficient for accurate estimation of secondary PK parameters including T1/2.
After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
Cmax of FGF401: Phase I
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
Castanon Alvarez E, Giallombardo M, Gil-Bazo I, Papadimitriou K, Pauwels P, Peeters M, Rolfo C. Looking into the "Garden of the Hesperides": new drugs for hepatocellular carcinoma. Minerva Chir. 2015 Apr;70(2):119-29. Epub 2015 Jan 23.
FG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
FG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
FG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
FG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
FG006
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
FG007
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
FG008
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
FG009
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
FG010
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
FG00011 subjects
FG0016 subjects
FG0025 subjects
FG00326 subjects
FG00419 subjects
FG0057 subjects
FG0066 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG00011 subjects
FG0016 subjects
FG0025 subjects
FG00326 subjects
FG00419 subjects
FG0057 subjects
FG0066 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Progressive disease
FG0009 subjects
FG0016 subjects
FG0023 subjects
FG00323 subjects
FG004
Subject/guardian decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase II Part
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00830 subjects
FG00936 subjects
FG01020 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
BG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
BG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
BG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
BG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
BG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
BG006
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
BG007
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
BG008
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
BG009
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
BG010
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG0016
BG0025
BG00326
BG00419
BG0057
BG0066
BG0076
BG00830
BG00936
BG01020
BG011172
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
18 y - <65 y
Title
Measurements
BG0006
BG0014
BG0023
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0011
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0009
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-limiting Toxicity (DLT): Phase I Only
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining set (DDS). A subject with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. A subject with multiple DLTs within a primary system organ class is counted only once in the total row.
Dose Determining Set: All subjects from safety set (Phase I) who either met the minimum exposure criterion and had sufficient safety evaluations or had experienced a DLT during the DLT evaluation period.
Posted
Number
Percentage of participants
Cycle 1 (C1) (21 days) for FGF401 single agent, Cycle 1 and Cycle 2 (C2) (42 days) for FGF401 and PDR001 combination
ID
Title
Description
OG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
OG006
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
OG007
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
OG00010
OG0016
OG0025
OG003
Title
Denominators
Categories
Any Primary system organ class (SOC)
Title
Measurements
OG00010.0
OG0010
OG0020
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
RP2D
120
The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fasted) is 120mg.
Other
OG004
Primary
Time to Progression (TTP): Group 1 & Group 2 (Phase II Only)
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis.
Group 1: HCC subjects form Asian countries; Group 2: HCC subjects form non-Asian countries
Full Analysis Set (FAS): Comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Median
90% Confidence Interval
months
approx. 4.5 years
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
Primary
Overall Response Rate (ORR) Based on Local Assessment: Group 3 (Phase II Only)
ORR is defined as the percentage of patients with a best overall response of CR or PR (RECIST v1.1).
FGF401 single agent-Phase II part - Group 3 (non-HCC, other solid tumors).
FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Number
95% Confidence Interval
Percentage of participants
approx. 4.5 years
ID
Title
Description
OG000
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
OG000
Secondary
Best Overall Response (BOR) by Investigator Assessment: Phase I and Phase II
BOR is the best response recorded from the start of the treatment until disease progression/recurrence. BOR is determined according to: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and unknown.
FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Count of Participants
Participants
approx. 4.5 years
ID
Title
Description
OG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Secondary
Overall Response Rate (ORR) by Investigator Assessment Phase I and FGF401 Single Agent Phase II Groups 1 & 2
ORR is defined as the proportion of patients with a best overall response of CR or PR (RECIST v1.1).
Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians)
FAS: The FAS comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Number
95% Confidence Interval
Percentage of participants
approx. 4.5 years
ID
Title
Description
OG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Secondary
Disease Control Rate (DCR) by Local Investigator Assessment Phase I and FGF401 Single Agent Phase II Groups 1, 2 & 3
DCR is the percentage of participants with a best overall response of CR or PR or SD per local assessment according to RECIST v1.1. Phase I part and FGF401 single agent Phase II Group 1 (HCC, Asians) and Group 2 (HCC, non-Asians) and Group 3 (non-HCC, other solid tumors).
FAS: The FAS comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Number
95% Confidence Interval
percentage of participants
approx. 4.5 years
ID
Title
Description
OG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Secondary
Time to Progression (TTP) in Participants Dosed With Single Agent FGF401 120 mg (Fasted & Fed) & With Combination FGF401 120 mg + PDR001 300 mg Q3W (Phase I)
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis.
The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to.
Posted
Median
90% Confidence Interval
months
approx. 4.5 years
ID
Title
Description
OG000
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
OG001
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG002
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Secondary
Overall Survival (OS) in Participants Dosed With Single Agent FGF401 120 mg (Fasted & Fed) and in Participants Dosed With Combination FGF401 120 mg and PDR001 300 mg Q3W (Phase I & II)
Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. Method used was Kaplan-Meier analysis.
FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Median
90% Confidence Interval
months
start of treatment to death, up to about 53 months
ID
Title
Description
OG000
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
OG001
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG002
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Secondary
Progression-free Survival (PFS) - FGF401 Single Agent Phase II: Group 3
Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Group 3 - non-HCC, other solid tumors. Method used was Kaplan-Meier analysis.
Full Analysis Set (FAS): Comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Median
95% Confidence Interval
months
4.5 years
ID
Title
Description
OG000
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
OG000
Secondary
Presence and/or Concentration of Anti-PDR001 Antibodies
Serum PDR001 concentrations as well as immunogenicity analysis were performed for all subjects receiving PDR001. Treatment-induced ADA-positive percentage was based on percentage subjects ADA-negative at baseline. Treatment-boosted ADA-positive percentage was based on subjects ADA-positive at baseline.
FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase I part were analyzed according to the treatment they had been assigned to.
Posted
Number
percentage of participants
Day 1 of Cycle 1 to 6, approx. 10 months after C1D1 and 150-day safety follow up (FU)
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
Secondary
Cmax of PDR001 in Combination With FGF401: Phase I
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
OG000
Secondary
AUClast and AUCtau of PDR001 in Combination of FGF401: Phase I
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1)
AUCtau (AUC0 504h): The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
Secondary
T1/2 of PDR001: Phase I
Due to the sparse PK sampling designed from PDR001, the PDR001 concentration data was insufficient for accurate estimation of secondary PK parameters including T1/2.
The PAS incl. all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, PAS incl. all subjects who provided an evaluable PK profile. Due to the sparse PK sampling designed for PDR001, PDR001 concentration data was insufficient for accurate estimation of secondary PK parameters including T1/2.
Posted
After the first dosing sample collection was at: C1D1 0hr , C1D1 1hr, C1D8 168hr, C1D15 336hr, C2D1 504hr; each cycle is 21 days
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
Secondary
Cmax of FGF401: Phase I
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
Secondary
Cmax of FGF401 in Combination With PDR001: Phase I
Cmax is the maximum (peak) observed plasma drug concentration (mass x volume-1)
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
C1D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
OG000
Secondary
AUCinf, AUClast & AUCtau of FGF401: Phase I
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1)
AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Secondary
AUCinf, AUClast & AUCtau of FGF401 in Combination With PDR001: Phase I
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1)
AUCtau: The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1)
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
C1D1 (0h, 0.5h, 1h, 2h, 3h, 4h, 6h, 12h, 24h)
ID
Title
Description
OG000
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG001
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
Units
Counts
Participants
Secondary
T1/2 of FGF401: Phase I
The elimination half-life associated with the terminal slope ( z) of a semi logarithmic concentration-time curve (time).
The PAS included all subjects who provided at least one evaluable drug concentration. For those requiring non-compartment analyses, the PAS included all subjects who provided an evaluable PK profile.
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
OG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
Post-Hoc
All Collected Deaths
This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of approx. 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination). Deaths post treatment survival follow up were collected after the on treatment period, up to approx. 4.5 years. Participants who had not died after study drug discontinuation were censored at the last date when the participant had some documented personal contact (visit or phone call) with the investigator.
FAS: The full analysis set (FAS) comprised all subjects who received at least one dose of study medication. Subjects enrolled in the Phase II part were analyzed by group.
Posted
Number
Participants
approx. 135.3 weeks, approx. 4.5 years
ID
Title
Description
OG000
Phase I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
OG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
OG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
Time Frame
This includes on-treatment deaths collected from first patient first treatment up to 30 days after drug discontinuation for a maximum of 135.3 weeks (treatment duration ranged from 0.1 to 135.3 weeks for FGF401 single agent and from 6.0 to 57.0 weeks for FGF401 plus PDR001 combination).
Description
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 or 150 days post treatment depending on single dose or combination dose.
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 I: 50 mg Fasted
Participants received single agent FGF401 50 mg while fasted
2
11
3
11
11
11
EG001
Phase I: 80 mg Fasted
Participants received single agent FGF401 80 mg while fasted
1
6
5
6
6
6
EG002
Phase I: 80 mg Fed
Participants received single agent FGF401 80 mg while fed
0
5
3
5
5
5
EG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
4
26
15
26
26
26
EG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
6
19
9
19
19
19
EG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
1
7
3
7
7
7
EG006
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
2
30
15
30
29
30
EG007
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
2
36
9
36
36
36
EG008
Phase II: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
2
20
8
20
20
20
EG009
All Patients of Single Agent FGF401
These were all the participants who received single dose of FGF401
20
160
70
160
159
160
EG010
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
0
6
0
6
6
6
EG011
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
0
6
2
6
6
6
EG012
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
0
12
2
12
12
12
EG013
All Patients
Overall participants in the in Phase I & Phase II of study
20
172
72
172
171
172
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG0030 affected26 at risk
EG0041 affected19 at risk
EG0050 affected7 at risk
EG0060 affected30 at risk
EG0070 affected36 at risk
EG0080 affected20 at risk
EG0091 affected160 at risk
EG0100 affected6 at risk
EG0110 affected6 at risk
EG0120 affected12 at risk
EG0131 affected172 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gait disturbance
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Biloma
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hepatic haematoma
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Varicella
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Liver carcinoma ruptured
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Tumour thrombosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Bronchostenosis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Aneurysm
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Bleeding varicose vein
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Inferior vena caval occlusion
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG0033 affected26 at risk
EG0042 affected19 at risk
EG0051 affected7 at risk
EG0065 affected30 at risk
EG0071 affected36 at risk
EG0085 affected20 at risk
EG00918 affected160 at risk
EG0102 affected6 at risk
EG0112 affected6 at risk
EG0124 affected12 at risk
EG01322 affected172 at risk
Hyperglobulinaemia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0023 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0022 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0008 affected11 at risk
EG0014 affected6 at risk
EG0024 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0021 affected5 at risk
EG003
Asthenia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected11 at risk
EG0012 affected6 at risk
EG0020 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Chills
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hernia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Malaise
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Oedema
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0003 affected11 at risk
EG0010 affected6 at risk
EG0022 affected5 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0003 affected11 at risk
EG0013 affected6 at risk
EG0022 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0004 affected11 at risk
EG0013 affected6 at risk
EG0022 affected5 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0004 affected11 at risk
EG0013 affected6 at risk
EG0021 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0021 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Transaminases increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0003 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0021 affected5 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0021 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0003 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Varicocele
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Bronchostenosis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0021 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0021 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected11 at risk
EG0012 affected6 at risk
EG0021 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected6 at risk
EG0020 affected5 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected6 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fed) is 120mg.
Other
OG007
RP2D
120
The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for FGF401 120mg.
Other
OG007
RP2D
300
The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for PDR001 300mg.
Other
OG000
30
OG00136
Title
Denominators
Categories
Title
Measurements
OG0002.6(1.3 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG0013.9(2.9 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Intervals for this Outcome Measure. Therefore, the upper limit is unavailable
20
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 16.8)
Participants received single agent FGF401 120 mg while fasted
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
OG006
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
OG007
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
OG008
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG009
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
OG010
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
OG00011
OG0016
OG0025
OG00326
OG00419
OG0057
OG0066
OG0076
OG00830
OG00936
OG01020
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Partial Response
Title
Measurements
OG0000
OG0011
OG0021
OG003
Stable Disease
Title
Measurements
OG0002
OG0011
OG0022
OG003
Progressive Disease
Title
Measurements
OG0007
OG0014
OG0021
OG003
Unknown
Title
Measurements
OG0002
OG0010
OG0021
OG003
Participants received single agent FGF401 120 mg while fasted
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
OG006
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
OG007
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
OG008
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG009
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
OG010
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
OG00011
OG0016
OG0025
OG00326
OG00419
OG0057
OG0066
OG0076
OG00830
OG00936
OG0100
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 28.5)
OG00116.7(0.4 to 64.1)
OG00220.0(0.5 to 71.6)
OG0033.8(0.1 to 19.6)
OG0040(0.0 to 17.6)
OG00514.3(0.4 to 57.9)
OG00616.7(0.4 to 64.1)
OG00716.7(0.4 to 64.1)
OG0086.7(0.8 to 22.1)
OG0095.6(0.7 to 18.7)
Participants received single agent FGF401 120 mg while fasted
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
OG006
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
OG007
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
OG008
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG009
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
OG010
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
OG00011
OG0016
OG0025
OG00326
OG00419
OG0057
OG0066
OG0076
OG00830
OG00936
OG01020
Title
Denominators
Categories
Title
Measurements
OG00018.2(2.3 to 51.8)
OG00133.3(4.3 to 77.7)
OG00260.0(14.7 to 94.7)
OG00350.0(29.9 to 70.1)
OG00447.4(24.4 to 71.1)
OG00571.4(29.0 to 96.3)
OG00650.0(11.8 to 88.2)
OG00750.0(11.8 to 88.2)
OG00843.3(25.5 to 62.6)
OG00961.1(43.5 to 76.9)
OG01030.0(11.9 to 54.3)
Units
Counts
Participants
OG00026
OG00119
OG0026
Title
Denominators
Categories
Title
Measurements
OG0004.1(1.6 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG0012.0(1.4 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG0025.3(3.0 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG003
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG004
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
OG005
PhaseII: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
Units
Counts
Participants
OG00026
OG00119
OG0026
OG00330
OG00436
OG00520
Title
Denominators
Categories
Title
Measurements
OG0007.0(5.1 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG0014.9(2.6 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG002NA(NA to NA)NA: did not observe enough events to calculate these parameters
OG0035.9(5.1 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG00410.9(7.9 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
OG0056.2(4.2 to NA)NA: it was pre-specified in the Statistical Plan to generate only one-sided 90% Confidence Interval for this Outcome Measure. Therefore, the upper limit is unavailable
20
Title
Denominators
Categories
Title
Measurements
OG0001.4(1.4 to 2.8)
OG0006
OG0016
Title
Denominators
Categories
ADA-negative
Title
Measurements
OG000100.0
OG00183.3
ADA-positive (i.e. ADA incidence)
Title
Measurements
OG0000
OG00116.7
Treatment-induced ADA-positive
Title
Measurements
OG0000
OG00120.0
Treatment-boosted ADA-positive
Title
Measurements
OG0000
OG0010
6
OG0016
Title
Denominators
Categories
Title
Measurements
OG00074.7± 43.0
OG00187.7± 5.4
OG0006
OG0016
Title
Denominators
Categories
AUClast
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000795± 34.5
OG001978± 15.8
AUC0-504h (n = 3, 6)
ParticipantsOG0003
ParticipantsOG0016
Title
Measurements
OG000760± 1.9
OG001
OG0000
OG0010
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
Units
Counts
Participants
OG00010
OG0016
OG0025
OG00326
OG00419
OG0057
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG00326
ParticipantsOG00419
ParticipantsOG0057
Title
Measurements
OG000698± 36.1
OG001967± 25.0
OG002659± 15.2
OG003
Cycle 1 Day 8
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00324
Cycle 2 Day 1
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00322
6
OG0016
Title
Denominators
Categories
Title
Measurements
OG000732± 26.8
OG0011450± 31.4
Participants received single agent FGF401 120 mg while fasted
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
Units
Counts
Participants
OG00010
OG0016
OG0025
OG00326
OG00419
OG0057
Title
Denominators
Categories
AUCinf C1D1
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG00324
ParticipantsOG00417
ParticipantsOG0057
Title
Measurements
OG0004920± 51.9
OG0015090± 32.9
OG0025560± 23.1
OG003
AUClast C1D1
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG00326
AUCtau C1D1
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG00326
AUCinf C1D8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00318
AUClast C1D8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00324
AUCtau C1D8
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00324
AUCinf C2D1
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00322
AUClast C2D1
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00322
AUCtau C2D1
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00322
OG0006
OG0016
Title
Denominators
Categories
AUCinf
Title
Measurements
OG0005030± 25.5
OG0017540± 37.0
AUClast
Title
Measurements
OG0004760± 25.0
OG0017280± 36.7
AUCtau
Title
Measurements
OG0004770± 24.4
OG0017280± 36.7
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
Units
Counts
Participants
OG00010
OG0016
OG0025
OG00326
OG00419
OG0057
Title
Denominators
Categories
C1D1
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG00324
ParticipantsOG00417
ParticipantsOG0057
Title
Measurements
OG0006.27± 16.2
OG0014.91± 31.6
OG0025.2± 8.8
OG003
C1D8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00318
C2D1
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00322
OG003
Phase I: 120 mg Fasted
Participants received single agent FGF401 120 mg while fasted
OG004
Phase I: 120 mg Fed
Participants received single agent FGF401 120 mg while fed
OG005
Phase I: 150 mg Fasted
Participants received single agent FGF401 150 mg while fasted
OG006
Phase II: Group 1 - FGF401 120 mg QD
Group 1 was comprised of HCC participants from Asian contrives who took single agent FGF401 120 mg QD while fasted
OG007
Phase II: Group 2 - FGF401 120 mg QD
Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted
OG008
Phase II: Group 3 - FGF401 120 mg QD
Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted
OG009
All Patients of Single Agent FGF401
These were all the participants who received single dose of FGF401
OG010
Phase I: FGF401 80 mg + PDR001 300 mg
Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted
OG011
Phase I: FGF401 120 mg + PDR001 300 mg
Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted
OG012
All Patients of Combination Dose
These were all the participants in the Phase I part who received combination dose of FGF401 and PDR001
OG013
All Patients
Overall participants in the in Phase I & Phase II of study