A Study to Evaluate the Efficacy and Safety of Pemigatini... | NCT02872714 | Trialant
NCT02872714
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Aug 14, 2025Actual
Enrollment
263Actual
Phase
Phase 2
Conditions
UC (Urothelial Cancer)
Interventions
pemigatinib
pemigatinib
Countries
United States
Belgium
Denmark
France
Germany
Israel
Italy
Japan
Netherlands
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02872714
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 54828-201
Secondary IDs
ID
Type
Description
Link
2016-001321-14
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Official Title
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03906357No longer available
Start Date
Jan 12, 2017Actual
Primary Completion Date
Feb 1, 2022Actual
Completion Date
Feb 1, 2022Actual
First Submitted Date
Aug 16, 2016
First Submission Date that Met QC Criteria
Aug 18, 2016
First Posted Date
Aug 19, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2023
Results First Submitted that Met QC Criteria
Feb 28, 2023
Results First Posted Date
Mar 24, 2023Actual
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
Aug 12, 2025
Last Update Posted Date
Aug 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
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
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.
Detailed Description
Not provided
Conditions Module
Conditions
UC (Urothelial Cancer)
Keywords
Urothelial carcinoma
fibroblast growth factor (FGF)
fibroblast growth factor receptor (FGFR)
FGF/FGFR alterations
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
263Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A-ID (Intermittent Dose) Pemigatinib
Experimental
Pemigatinib in subjects with FGFR3 mutations or fusions.
Drug: pemigatinib
Cohort A-CD (Continuous Dose) Pemigatinib
Experimental
Pemigatinib in subjects with FGFR3 mutations or fusions.
Drug: pemigatinib
Cohort B Pemigatinib
Experimental
Pemigatinib in subjects with other FGF/FGFR alterations.
Drug: pemigatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pemigatinib
Drug
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Cohort A-ID (Intermittent Dose) Pemigatinib
Cohort B Pemigatinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1138 days
Secondary Outcomes
Measure
Description
Time Frame
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
20 years and older in Japan
Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Life expectancy ≥ 12 weeks.
Radiographically measurable per RECIST v1.1.
Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.
Exclusion Criteria:
Prior receipt of a selective FGFR inhibitor.
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.
Zhang C, Huang MN, Shan JQ, Hu ZJ, Li ZW, Liu JY. Pemigatinib, a selective FGFR inhibitor overcomes ABCB1-mediated multidrug resistance in cancer cells. Biochem Biophys Res Commun. 2024 Jan 8;691:149314. doi: 10.1016/j.bbrc.2023.149314. Epub 2023 Nov 24.
Necchi A, Pouessel D, Leibowitz R, Gupta S, Flechon A, Garcia-Donas J, Bilen MA, Debruyne PR, Milowsky MI, Friedlander T, Maio M, Gilmartin A, Li X, Veronese ML, Loriot Y. Pemigatinib for metastatic or surgically unresectable urothelial carcinoma with FGF/FGFR genomic alterations: final results from FIGHT-201. Ann Oncol. 2024 Feb;35(2):200-210. doi: 10.1016/j.annonc.2023.10.794. Epub 2023 Nov 11.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
The study was conducted at a total of 73 study centers in 11 countries (United States, France, Italy, Spain, Israel, Belgium, United Kingdom, Germany, Japan, Denmark, and the Netherlands).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Mar 9, 2020
Jan 30, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
INCB054828
pemigatinib
Drug
Pemigatinib once a day by mouth continuously.
Cohort A-CD (Continuous Dose) Pemigatinib
INCB054828
up to 817 days
ORR in Participants With All Other FGF/FGFR Alterations
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1198 days
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
up to 1198 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
up to approximately 25 weeks
Progression-free Survival (PFS)
PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
up to 1138 days
Duration of Response (DOR)
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed
up to 1075 days
Overall Survival
Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.
up to 1610 days
San Diego
California
92123
United States
UCSF Helen Diller Family Comprehensive Care Center
San Francisco
California
94158
United States
Rocky Mountain Cancer Centers
Boulder
Colorado
80303
United States
Calaway-Young Cancer Center at Valley View Hospital
Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo
Candiolo
20133
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
20133
Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
Naples
80131
Italy
Ospedale degli Infermi
Rimini
47923
Italy
University Campus Bio-Medico di Roma
Rome
00128
Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
71013
Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena
53100
Italy
San Camillo-Forlanini Hospital
Siena
53100
Italy
Kyushu University Hospital
Fukuoka
8128582
Japan
Saitama Medical University International Medical Center
Hidaka-shi
350-1298
Japan
Hirosaki University Hospital
Hirosaki-shi
036-8563
Japan
Teikyo University Hospital
Itabashi-ku
173-8606
Japan
Nihon University Itabashi Hospital
Itabashi-ku
173-8610
Japan
Nara Medical University Hospital
Kashihara-shi
634-8522
Japan
Osaka International Cancer Institute
Osaka
541-8567
Japan
Saitama Cancer Center
Saitama
362-0806
Japan
Osaka University Hospital
Suita-shi
565-0871
Japan
Jichi Medical University Hospital
Tochigi
329-0498
Japan
VU Medisch Centrum
Amsterdam
1081 HV
Netherlands
Zorgsaam Ziekenhuis
Terneuzen
4535 PA
Netherlands
HagaZiekenhuis Van Den Haag
The Hague
Netherlands
Viecuri Medisch Centrum
Venlo
5912 BL
Netherlands
Clinica Universidad de Navarra
Pamplona
Navarre
31008
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
Girona
17007
Spain
Centro Integral Oncologico Clara Campal
Madrid
28050
Spain
University College London Hospitals
London
Greater London
NW1 2PG
United Kingdom
Guy's Hospital
London
Greater London
SE1 9RT
United Kingdom
Charing Cross Hospital
London
Greater London
W6 8RF
United Kingdom
Nottingham University Hospitals City Campus
Nottingham
Nottinghamshire
NG5 1PB
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow
Strathclyde
G12 OYN
United Kingdom
Queen Elizabeth Hospital
Birmingham
West Midlands
B15 2TH
United Kingdom
FG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
FG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
FG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
FG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
FG000103 subjects
FG00144 subjects
FG0029 subjects
FG003101 subjects
FG0043 subjects
COMPLETED
FG00010 subjects
FG0012 subjects
FG0021 subjects
FG00313 subjects
FG0041 subjects
NOT COMPLETED
FG00093 subjects
FG00142 subjects
FG0028 subjects
FG00388 subjects
FG0042 subjects
Type
Comment
Reasons
Progressive Disease
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Death
FG00087 subjects
FG00136 subjects
FG0028 subjects
FG00381 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0032 subjects
FG004
Captured as Other
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
BG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
BG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
BG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
BG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000103
BG00144
BG0029
BG003101
BG0043
BG005260
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067.6± 9.09
BG00165.1± 10.83
BG00269.3± 7.98
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00114
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00064
BG00129
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Efficacy Evaluable Population: all participants enrolled in the study who had a known FGF/FGFR alteration confirmed by the sponsor's central laboratory and who had received at least 1 dose of study drug. The confidence interval was calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1138 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
OG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG00317.8(10.92 to 26.70)
Secondary
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 817 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
Secondary
ORR in Participants With All Other FGF/FGFR Alterations
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1198 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
OG001
Secondary
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1198 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
Safety Population: all participants enrolled in the study who had received at least 1 dose of study drug
Posted
Count of Participants
Participants
up to approximately 25 weeks
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
OG001
Secondary
Progression-free Survival (PFS)
PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Efficacy Evaluable Population. The "Other-ID" and "Other-CD" treatment groups were not included in the Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 1138 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
OG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Secondary
Duration of Response (DOR)
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed
Efficacy Evaluable Population. The "Other-ID" and "Other-CD" treatment groups were not included in the Efficacy Evaluable Population. Only participants with a CR or PR were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 1075 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
Secondary
Overall Survival
Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.
Efficacy Evaluable Population. The "Other-ID" and "Other-CD" treatment groups were not included in the Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 1610 days
ID
Title
Description
OG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
OG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Time Frame
Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Description
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
88
103
45
103
101
103
EG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
39
44
26
44
43
44
EG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
8
9
3
9
9
9
EG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
83
101
48
101
99
101
EG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
2
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG0031 events1 affected101 at risk
EG0040 events0 affected3 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0003 events2 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0014 events4 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Anastomotic haemorrhage
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Bladder mass
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Bladder outlet obstruction
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Blood urine present
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Detachment of retinal pigment epithelium
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Device related infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Disease progression
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Empyema
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Gait disturbance
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Gallbladder enlargement
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
General physical health deterioration
General disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Intestinal infarction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0004 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Keratitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Malaise
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Optic neuropathy
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pancreatic mass
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Peripheral nerve paresis
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0003 events2 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Polyp
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Spinal cord infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Stomal hernia
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Sudden death
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract stoma complication
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urine output decreased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urostomy complication
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Vasculitis necrotising
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0012 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Viral oesophagitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
White blood cell count increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Wound infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00028 events20 affected103 at risk
EG00112 events11 affected44 at risk
EG0021 events1 affected9 at risk
EG0039 events7 affected101 at risk
EG0042 events2 affected3 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected103 at risk
EG0014 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected103 at risk
EG0016 events5 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00050 events49 affected103 at risk
EG00116 events16 affected44 at risk
EG0027 events7 affected9 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG00022 events19 affected103 at risk
EG00110 events10 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Arcus lipoides
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00022 events19 affected103 at risk
EG0017 events6 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG0006 events5 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 24
Systematic Assessment
EG00031 events28 affected103 at risk
EG0019 events9 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00022 events18 affected103 at risk
EG0016 events6 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Blepharitis
Eye disorders
MedDRA 24
Systematic Assessment
EG00010 events8 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG00019 events17 affected103 at risk
EG0015 events5 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 24
Systematic Assessment
EG00011 events9 affected103 at risk
EG0016 events4 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Candida infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Cataract
Eye disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Chest pain
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Chills
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0005 events4 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00046 events36 affected103 at risk
EG00113 events11 affected44 at risk
EG0024 events4 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Corneal neovascularisation
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00018 events15 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00038 events32 affected103 at risk
EG00112 events11 affected44 at risk
EG0024 events4 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00012 events8 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Detachment of macular retinal pigment epithelium
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00089 events53 affected103 at risk
EG00128 events19 affected44 at risk
EG0028 events6 affected9 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24
Systematic Assessment
EG00014 events12 affected103 at risk
EG0014 events4 affected44 at risk
EG0022 events1 affected9 at risk
EG003
Dry eye
Eye disorders
MedDRA 24
Systematic Assessment
EG00027 events21 affected103 at risk
EG0017 events7 affected44 at risk
EG0024 events4 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00035 events33 affected103 at risk
EG00113 events13 affected44 at risk
EG0027 events7 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00023 events21 affected103 at risk
EG0016 events6 affected44 at risk
EG0025 events4 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG00035 events32 affected103 at risk
EG00110 events9 affected44 at risk
EG0026 events6 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00016 events10 affected103 at risk
EG0011 events1 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0005 events4 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected103 at risk
EG0016 events4 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected103 at risk
EG0014 events3 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0005 events4 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00015 events13 affected103 at risk
EG0013 events3 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Eye disorder
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Eye haematoma
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Eye pain
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Eyelid pain
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG00044 events36 affected103 at risk
EG00117 events16 affected44 at risk
EG0023 events3 affected9 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Glaucoma
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG00011 events8 affected103 at risk
EG0017 events6 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0015 events5 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00012 events11 affected103 at risk
EG0012 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0013 events3 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected103 at risk
EG0017 events4 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00039 events35 affected103 at risk
EG00115 events13 affected44 at risk
EG0024 events4 affected9 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0008 events8 affected103 at risk
EG0014 events4 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0013 events3 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0009 events7 affected103 at risk
EG00110 events6 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00020 events13 affected103 at risk
EG0014 events3 affected44 at risk
EG0022 events1 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG00011 events10 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Hypouricaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Influenza
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Influenza like illness
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0012 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG00013 events12 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Keratitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected103 at risk
EG0011 events1 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 24
Systematic Assessment
EG0003 events2 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0014 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0017 events6 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Meibomian gland dysfunction
Eye disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0014 events4 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0022 events1 affected9 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00011 events9 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0008 events6 affected103 at risk
EG0011 events1 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0015 events5 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0009 events8 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0008 events7 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Nail toxicity
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0010 events0 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00039 events28 affected103 at risk
EG00117 events13 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0019 events8 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events4 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00010 events10 affected103 at risk
EG0017 events6 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected103 at risk
EG0013 events3 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0004 events3 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected103 at risk
EG0015 events4 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Pain
General disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0013 events3 affected44 at risk
EG0022 events2 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00014 events12 affected103 at risk
EG0015 events4 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00010 events8 affected103 at risk
EG0013 events3 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0009 events9 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG00019 events14 affected103 at risk
EG0016 events6 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0008 events8 affected103 at risk
EG0012 events2 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00070 events48 affected103 at risk
EG00114 events13 affected44 at risk
EG0023 events3 affected9 at risk
EG003
Subretinal fluid
Eye disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Trichiasis
Eye disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Trichomegaly
Eye disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected103 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG00031 events25 affected103 at risk
EG00116 events10 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected103 at risk
EG0013 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 24
Systematic Assessment
EG0003 events3 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0005 events4 affected103 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00029 events19 affected103 at risk
EG00115 events10 affected44 at risk
EG0020 events0 affected9 at risk
EG003
Weight decreased
Investigations
MedDRA 24
Systematic Assessment
EG00021 events19 affected103 at risk
EG0012 events2 affected44 at risk
EG0021 events1 affected9 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
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000705477
pemigatinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
0 subjects
0 subjects
0 subjects
0 subjects
68.5
± 9.39
BG00460.3± 9.02
BG00567.5± 9.53
1
BG00323
BG0041
BG00568
Male
BG00074
BG00130
BG0028
BG00378
BG0042
BG005192
6
BG00363
BG0042
BG005164
Black or African-American
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
Asian
Title
Measurements
BG0002
BG0012
BG0020
BG00312
BG0041
BG00517
Turkish
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
Persian
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
Unknown or Not Reported
Title
Measurements
BG00030
BG00113
BG0021
BG00322
BG0040
BG00566
Missing
Title
Measurements
BG0006
BG0010
BG0020
BG0034
BG0040
BG00510
0
BG0032
BG0040
BG0053
Not Hispanic or Latino
Title
Measurements
BG00064
BG00132
BG0027
BG00366
BG0042
BG005171
Not Reported
Title
Measurements
BG00023
BG00111
BG0022
BG00322
BG0041
BG00559
Unknown
Title
Measurements
BG0005
BG0011
BG0020
BG0033
BG0040
BG0059
Captured as Other
Title
Measurements
BG0005
BG0010
BG0020
BG0036
BG0040
BG00511
Missing
Title
Measurements
BG0005
BG0010
BG0020
BG0032
BG0040
BG0057
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
101
OG0040
OG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG000103
OG0010
OG0020
OG0030
OG0040
Title
Denominators
Categories
Title
Measurements
OG00023.3(15.54 to 32.66)
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG0000
OG00144
OG0020
OG0030
OG0040
Title
Denominators
Categories
Title
Measurements
OG0016.8(1.43 to 18.66)
OG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG005
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG006
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG007
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG005147
OG006204
OG007248
Title
Denominators
Categories
Title
Measurements
OG00518.4(12.47 to 25.59)
OG00620.6(15.26 to 26.79)
OG00718.1(13.55 to 23.52)
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG000103
OG00144
OG0029
OG003101
OG0043
Title
Denominators
Categories
Title
Measurements
OG000103
OG00144
OG0029
OG003100
OG0043
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG000103
OG00144
OG0020
OG003101
OG0040
Title
Denominators
Categories
Title
Measurements
OG0004.27(3.91 to 6.05)
OG0012.04(1.87 to 2.17)
OG0034.04(3.45 to 4.17)
OG001
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
Units
Counts
Participants
OG00024
OG0013
OG0020
OG00318
OG0040
Title
Denominators
Categories
Title
Measurements
OG0006.21(4.60 to 7.95)
OG00110.02(8.38 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0036.23(4.14 to 8.25)
OG002
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG003
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
OG004
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of > 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.