Efficacy and Safety of Pemigatinib in Subjects With Advan... | NCT02924376 | Trialant
NCT02924376
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Aug 14, 2025Actual
Enrollment
147Actual
Phase
Phase 2
Conditions
Cholangiocarcinoma
Interventions
Pemigatinib
Countries
United States
Belgium
France
Germany
Israel
Italy
Japan
South Korea
Spain
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02924376
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 54828-202
Secondary IDs
ID
Type
Description
Link
2016-002422-36
EudraCT Number
Brief Title
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Official Title
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)
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 16, 2017Actual
Primary Completion Date
Feb 1, 2022Actual
Completion Date
Feb 1, 2022Actual
First Submitted Date
Oct 4, 2016
First Submission Date that Met QC Criteria
Oct 4, 2016
First Posted Date
Oct 5, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 26, 2023
Results First Submitted that Met QC Criteria
Jan 26, 2023
Results First Posted Date
Feb 23, 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
Not provided
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 evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Cholangiocarcinoma
Keywords
Cholangiocarcinoma
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
147Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A Pemigatinib
Experimental
Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
Drug: Pemigatinib
Cohort B Pemigatinib
Experimental
Pemigatinibin subjects with other FGF/FGFR alterations
Drug: Pemigatinib
Cohort C Pemigatinib
Experimental
Pemigatinib in subjects negative for FGF/FGFR alteration
Drug: Pemigatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pemigatinib
Drug
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Cohort A Pemigatinib
Cohort B Pemigatinib
Cohort C Pemigatinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
up to 1527 days
Secondary Outcomes
Measure
Description
Time Frame
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed cholangiocarcinoma.
Radiographically measurable or evaluable disease per RECIST v1.1.
Tumor assessment for FGF/FGFR gene alteration status.
Documented disease progression after at least 1 line of prior systemic therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Life expectancy ≥ 12 weeks.
Exclusion Criteria:
Prior receipt of a selective FGFR inhibitor.
History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
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. Topical ketoconazole will be allowed.
Patel TH, Marcus L, Horiba MN, Donoghue M, Chatterjee S, Mishra-Kalyani PS, Schuck RN, Li Y, Zhang X, Fourie Zirkelbach J, Charlab R, Liu J, Yang Y, Lemery SJ, Pazdur R, Theoret MR, Fashoyin-Aje LA. FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement. Clin Cancer Res. 2023 Mar 1;29(5):838-842. doi: 10.1158/1078-0432.CCR-22-2036.
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.
This study enrolled participants at 68 study sites in the United States, South Korea, United Kingdom, France, Italy, Thailand, Germany, Belgium, Israel, Spain, Japan, and Taiwan.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
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
Apr 2, 2020
Jan 26, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
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
up to 424 days
ORR in All Participants With 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
up to 1527 days
ORR in Participants Negative for 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
up to 143 days
Progression-free Survival (PFS)
PFS was defined as the length of time from the first dose of 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 50.17 months
Duration of Response (DOR)
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee 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. PD: progression of a target or non-target lesion or presence of a new lesion.
up to 47.11 months
Disease Control Rate (DCR)
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to 1527 days
Overall Survival
Overall survival was defined as the length of time from the first dose of study drug (Day 1) until the date of death due to any cause.
up to 51.32 months
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 defined as any adverse event 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 1584 days
First-order Absorption Rate Constant (ka) of Pemigatinib
First-order absorption rate constant is defined as the rate at which a drug enters into the system.
Bibeau K, Feliz L, Lihou CF, Ren H, Abou-Alfa GK. Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response. JCO Precis Oncol. 2022 Apr;6:e2100414. doi: 10.1200/PO.21.00414.
Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, Paulson AS, Borad MJ, Gallinson D, Murphy AG, Oh DY, Dotan E, Catenacci DV, Van Cutsem E, Ji T, Lihou CF, Zhen H, Feliz L, Vogel A. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May;21(5):671-684. doi: 10.1016/S1470-2045(20)30109-1. Epub 2020 Mar 20.
FG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
FG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
FG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
FG000108 subjects
FG00120 subjects
FG00217 subjects
FG0032 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG000108 subjects
FG00120 subjects
FG00217 subjects
FG0032 subjects
Type
Comment
Reasons
Progressive Disease
FG0004 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Death
FG00073 subjects
FG00118 subjects
FG00215 subjects
FG0032 subjects
Lost to Follow-up
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Study Terminated by Sponsor
FG00019 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0007 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
Rolled Over to Another Study
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000108
BG00120
BG00217
BG0032
BG004147
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
BG00055.2± 12.00
BG00161.9± 10.99
BG00265.6± 7.12
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00066
BG00111
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00079
BG0019
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0002
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 FGFR2 Rearrangements or Fusions
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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Efficacy Evaluable Population (EEP): all participants who received ≥1 dose of pemigatinib and had a known FGF/FGFR alteration or, in the United States, were negative for FGF/FGFR alterations based on central genomics laboratory results. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1527 days
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000108
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG00037.0(27.94 to 46.86)
Secondary
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 424 days
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Secondary
ORR in All Participants With 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1527 days
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Secondary
ORR in Participants Negative for 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 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. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 143 days
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Secondary
Progression-free Survival (PFS)
PFS was defined as the length of time from the first dose of 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. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 50.17 months
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Secondary
Duration of Response (DOR)
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee 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. PD: progression of a target or non-target lesion or presence of a new lesion.
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.
Posted
Median
95% Confidence Interval
months
up to 47.11 months
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Secondary
Disease Control Rate (DCR)
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 1527 days
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Secondary
Overall Survival
Overall survival was defined as the length of time from the first dose of study drug (Day 1) until the date of death due to any cause.
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 51.32 months
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
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 defined as any adverse event 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 enrolled participants who received at least 1 dose of pemigatinib
Posted
Count of Participants
Participants
up to 1584 days
ID
Title
Description
OG000
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Secondary
First-order Absorption Rate Constant (ka) of Pemigatinib
First-order absorption rate constant is defined as the rate at which a drug enters into the system.
Pharmacokinetic (PK) Population: all participants contributing at least one sample for PK analysis
Participants with FGFR2 rearrangements or fusions (Cohort A), participants with all other FGF/FGFR alterations (Cohort B), participants with no FGF/FGFR alterations (Cohort C; United States only), and participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally (Other) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Participants with FGFR2 rearrangements or fusions (Cohort A), participants with all other FGF/FGFR alterations (Cohort B), participants with no FGF/FGFR alterations (Cohort C; United States only), and participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally (Other) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Vc/F of Pemigatinib
Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.
Participants with FGFR2 rearrangements or fusions (Cohort A), participants with all other FGF/FGFR alterations (Cohort B), participants with no FGF/FGFR alterations (Cohort C; United States only), and participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally (Other) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Vp/F of Pemigatinib
Vp/F is defined as the apparent volume of distribution for the tissue (peripheral) compartment.
Participants with FGFR2 rearrangements or fusions (Cohort A), participants with all other FGF/FGFR alterations (Cohort B), participants with no FGF/FGFR alterations (Cohort C; United States only), and participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally (Other) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000
Time Frame
up to 1584 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: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
76
108
46
108
108
108
EG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
18
20
10
20
20
20
EG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
15
17
12
17
17
17
EG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
2
2
0
2
2
2
EG004
Total
Total
111
147
68
147
147
147
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0006 events4 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG0030 events0 affected2 at risk
EG0049 events7 affected147 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Biloma
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Chills
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0008 events5 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Complication associated with device
General disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Device leakage
Product Issues
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Device occlusion
Product Issues
MedDRA 24
Systematic Assessment
EG0003 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Enterobacter bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Malignant biliary obstruction
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0004 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG0007 events5 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0005 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0022 events1 affected17 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00010 events9 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG0030 events0 affected2 at risk
EG00411 events10 affected147 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00039 events22 affected108 at risk
EG0013 events3 affected20 at risk
EG0023 events3 affected17 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00016 events11 affected108 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Acinetobacter bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG00016 events12 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00066 events64 affected108 at risk
EG0014 events4 affected20 at risk
EG0023 events3 affected17 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG00027 events16 affected108 at risk
EG0012 events2 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00052 events37 affected108 at risk
EG0018 events5 affected20 at risk
EG0023 events2 affected17 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG00016 events9 affected108 at risk
EG0013 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Asthenia
General disorders
MedDRA 24
Systematic Assessment
EG00034 events15 affected108 at risk
EG0019 events4 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00034 events27 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Blood 1,25-dihydroxycholecalciferol decreased
Investigations
MedDRA 24
Systematic Assessment
EG0004 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Blood 1,25-dihydroxycholecalciferol increased
Investigations
MedDRA 24
Systematic Assessment
EG0003 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Blood 25-hydroxycholecalciferol decreased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24
Systematic Assessment
EG00016 events12 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24
Systematic Assessment
EG0009 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Blood chloride decreased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0014 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG00012 events9 affected108 at risk
EG0012 events2 affected20 at risk
EG0024 events4 affected17 at risk
EG003
Blood parathyroid hormone decreased
Investigations
MedDRA 24
Systematic Assessment
EG0004 events3 affected108 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Blood urea increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Candida infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Cataract
Eye disorders
MedDRA 24
Systematic Assessment
EG00010 events7 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Chills
General disorders
MedDRA 24
Systematic Assessment
EG0008 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0004 events3 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Chorioretinal scar
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Coma
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0009 events7 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00068 events46 affected108 at risk
EG0016 events5 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00012 events10 affected108 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0006 events5 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00039 events34 affected108 at risk
EG00110 events7 affected20 at risk
EG0028 events7 affected17 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00017 events16 affected108 at risk
EG0012 events1 affected20 at risk
EG0024 events3 affected17 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected108 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Device related infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG000169 events58 affected108 at risk
EG00115 events5 affected20 at risk
EG0026 events6 affected17 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24
Systematic Assessment
EG00023 events19 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Dry eye
Eye disorders
MedDRA 24
Systematic Assessment
EG00045 events38 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00049 events42 affected108 at risk
EG0015 events5 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00033 events30 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG00049 events45 affected108 at risk
EG0015 events3 affected20 at risk
EG0023 events3 affected17 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00017 events14 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00012 events10 affected108 at risk
EG0013 events3 affected20 at risk
EG0023 events3 affected17 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Episcleritis
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00024 events19 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0009 events8 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Eye discharge
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Eye pain
Eye disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG00013 events8 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG00060 events50 affected108 at risk
EG0016 events5 affected20 at risk
EG0029 events9 affected17 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Gait disturbance
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00014 events13 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Growth of eyelashes
Eye disorders
MedDRA 24
Systematic Assessment
EG0008 events8 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG00032 events20 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0009 events9 affected108 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00018 events16 affected108 at risk
EG0015 events4 affected20 at risk
EG0022 events1 affected17 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0004 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG000109 events60 affected108 at risk
EG00114 events13 affected20 at risk
EG00213 events12 affected17 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24
Systematic Assessment
EG00011 events9 affected108 at risk
EG0014 events3 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0005 events4 affected108 at risk
EG0013 events3 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0012 events2 affected20 at risk
EG0023 events3 affected17 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00010 events9 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00010 events6 affected108 at risk
EG0016 events4 affected20 at risk
EG0026 events4 affected17 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00049 events28 affected108 at risk
EG0016 events4 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0009 events5 affected108 at risk
EG0012 events2 affected20 at risk
EG0023 events2 affected17 at risk
EG003
Hypovitaminosis
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Influenza like illness
General disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG00013 events13 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Keratitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 24
Systematic Assessment
EG00012 events7 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Lipase increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24
Systematic Assessment
EG0005 events4 affected108 at risk
EG0012 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Malaise
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00012 events11 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00019 events15 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00012 events12 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00014 events11 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0009 events8 affected108 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00014 events13 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0008 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00071 events45 affected108 at risk
EG00110 events7 affected20 at risk
EG0027 events7 affected17 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected108 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0008 events7 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0012 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24
Systematic Assessment
EG00021 events16 affected108 at risk
EG0014 events4 affected20 at risk
EG0026 events6 affected17 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00010 events9 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00010 events10 affected108 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00014 events13 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0006 events5 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG00013 events11 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Pain
General disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00041 events26 affected108 at risk
EG0014 events3 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00034 events23 affected108 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0009 events9 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Performance status decreased
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24
Systematic Assessment
EG00015 events8 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0004 events3 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Presbyopia
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00015 events13 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0008 events8 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG00020 events11 affected108 at risk
EG0013 events3 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00014 events12 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00074 events46 affected108 at risk
EG00110 events6 affected20 at risk
EG0023 events3 affected17 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Subretinal fluid
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0004 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0009 events7 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Thirst
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Transaminases increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected108 at risk
EG0015 events3 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Tri-iodothyronine free increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Trichiasis
Eye disorders
MedDRA 24
Systematic Assessment
EG00011 events11 affected108 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Trichomegaly
Eye disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Trichomoniasis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0008 events7 affected108 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG00033 events21 affected108 at risk
EG0013 events2 affected20 at risk
EG0022 events2 affected17 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00010 events10 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected108 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00055 events35 affected108 at risk
EG0013 events3 affected20 at risk
EG0025 events4 affected17 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected108 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Weight decreased
Investigations
MedDRA 24
Systematic Assessment
EG00023 events20 affected108 at risk
EG0014 events4 affected20 at risk
EG0021 events1 affected17 at risk
EG003
Weight increased
Investigations
MedDRA 24
Systematic Assessment
EG0007 events4 affected108 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected17 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
41.0
± 14.14
BG00457.1± 12.08
7
BG0031
BG00485
Male
BG00042
BG0019
BG00210
BG0031
BG00462
14
BG0032
BG004104
Black or African American
Title
Measurements
BG0007
BG0010
BG0021
BG0030
BG0048
Asian
Title
Measurements
BG00012
BG00111
BG0020
BG0030
BG00423
American-Indian/Alaska Native
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
Captured as "Other"
Title
Measurements
BG0004
BG0010
BG0021
BG0030
BG0045
Missing
Title
Measurements
BG0006
BG0010
BG0020
BG0030
BG0046
4
BG0030
BG0046
Not Hispanic or Latino
Title
Measurements
BG00088
BG00118
BG00213
BG0032
BG004121
Not Reported
Title
Measurements
BG00015
BG0010
BG0020
BG0030
BG00415
Unknown
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
Captured as "Other"
Title
Measurements
BG0002
BG0012
BG0020
BG0030
BG0044
0
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG0000
OG00120
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0010.0(0.0 to 16.84)
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG004
Cohort A + Cohort B
Participants with FGFR2 rearrangements 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 a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG004128
Title
Denominators
Categories
Title
Measurements
OG00431.3(23.35 to 40.04)
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG0000
OG0010
OG00217
OG0030
Title
Denominators
Categories
Title
Measurements
OG0020.0(0.0 to 19.51)
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000108
OG00120
OG00217
OG0030
Title
Denominators
Categories
Title
Measurements
OG0007.03(6.08 to 10.48)
OG0012.10(1.18 to 4.86)
OG0021.51(1.38 to 1.84)
OG001
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00040
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0009.13(6.01 to 14.49)
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000108
OG00120
OG00217
OG0030
Title
Denominators
Categories
Title
Measurements
OG00082.4(73.9 to 89.1)
OG00140.0(19.1 to 63.9)
OG00217.6(3.8 to 43.4)
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000108
OG00120
OG00217
OG0030
Title
Denominators
Categories
Title
Measurements
OG00017.48(14.36 to 22.93)
OG0016.70(2.10 to 10.55)
OG0023.98(1.97 to 4.60)
OG002
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.