A Study of Erdafitinib in Participants With Metastatic or... | NCT03473743 | Trialant
NCT03473743
Sponsor
Janssen Research & Development, LLC
Status
Active, not recruiting
Last Update Posted
Mar 30, 2026Actual
Enrollment
125Actual
Phase
Phase 1Phase 2
Conditions
Urothelial Carcinoma
Interventions
Erdafitinib
Cetrelimab
Cisplatin
Carboplatin
Countries
United States
Belarus
Belgium
Brazil
France
Italy
Poland
Russia
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03473743
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108445
Secondary IDs
ID
Type
Description
Link
42756493BLC2002
Other Identifier
Janssen Research & Development, LLC
2017-001980-19
EudraCT Number
2023-510295-31-00
Registry Identifier
EUCT number
Brief Title
A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
Official Title
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03825484Approved for marketing
Start Date
Apr 5, 2018Actual
Primary Completion Date
Sep 30, 2022Actual
Completion Date
Dec 31, 2026Estimated
First Submitted Date
Mar 14, 2018
First Submission Date that Met QC Criteria
Mar 21, 2018
First Posted Date
Mar 22, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 29, 2023
Results First Submitted that Met QC Criteria
Sep 29, 2023
Results First Posted Date
Oct 25, 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
Mar 16, 2026
Last Update Posted Date
Mar 30, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
Detailed Description
This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.
Conditions Module
Conditions
Urothelial Carcinoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
125Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1b: Dose Escalation
Experimental
Two dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Drug: Erdafitinib
Drug: Cetrelimab
Drug: Cisplatin
Drug: Carboplatin
Phase 2: Dose Expansion
Experimental
The participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).
Drug: Erdafitinib
Drug: Cetrelimab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Erdafitinib
Drug
Participants will receive erdafitinib orally.
Phase 1b: Dose Escalation
Phase 2: Dose Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Up to 8 weeks
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
From Day 1 up to 36 months
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
From Day 1 up to 36 months
Secondary Outcomes
Measure
Description
Time Frame
Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Up to 6 years 1 month
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Up to 6 years 1 month
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Metastatic or locally advanced urothelial cancer
Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL/min) to receive carboplatin and >60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (Ë‚) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2
Exclusion Criteria:
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
Active malignancies requiring concurrent therapy other than urothelial cancer
Symptomatic central nervous system metastases
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Loriot Y, Powles T, Moreno V, Kang TW, Cicin I, Girvin A, Akapame S, O'Hagan A, Zhu W, Tammaro M, Thomas S, Triantos S, Siefker-Radtke AO. Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study. J Clin Oncol. 2026 Mar 10;44(8):676-684. doi: 10.1200/JCO-25-00826. Epub 2026 Jan 15.
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 11, 2022
Aug 21, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Georgia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential 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
JNJ-42756493
Cetrelimab
Drug
Participants will receive cetrelimab by intravenous infusion.
Phase 1b: Dose Escalation
Phase 2: Dose Expansion
JNJ-63723283
Cisplatin
Drug
Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
Phase 1b: Dose Escalation
Carboplatin
Drug
Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.
Phase 1b: Dose Escalation
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Up to 6 years 1 month
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Up to 6 years 1 month
Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Up to 6 years 1 month
Phase 2: Number of Participants With Abnormal Laboratory Values
Up to 6 years 1 month
Phase 2: Duration of Response (DoR)
Up to 6 years 1 month
Phase 2: Time to Response (TTR)
Up to 6 years 1 month
Phase 2: Progression-free Survival (PFS)
Up to 6 years 1 month
Phase 2: Overall Survival (OS)
Up to 6 years 1 month
Louisville
Kentucky
40202
United States
Maryland Oncology Hematology, PA
Rockville
Maryland
20850
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
Weill Cornell Medical College - NY Presbyterian Hospital
New York
New York
10021
United States
White Plains Hospital Center for Cancer Care
White Plains
New York
10601
United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte
North Carolina
28204
United States
Toledo Clinic Cancer Centers
Toledo
Ohio
43623-3536
United States
Penn State Hershey Cancer Institute
Hershey
Pennsylvania
17033
United States
Texas Oncology, P.A.
Fort Worth
Texas
76104
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Virginia Oncology Associates
Norfolk
Virginia
23502
United States
Brest Regional Oncology Dispensary
Brest
224027
Belarus
Grodno University Hospital
Grodno
230017
Belarus
Gomel Regional Clinical Oncology Dispensary
Homyel
246012
Belarus
State Institution N.N. Alexandrov Republican Scientific and
Lesnoy
223040
Belarus
Minsk city Clinical Oncological Dispensary
Minsk
220013
Belarus
Mogilev Regional Hospital
Mogilev
212018
Belarus
Vitebsk Regional Clinical Hospital
Vitebsk
210603
Belarus
ULB Hôpital Erasme
Brussels
1070
Belgium
Cliniques Universitaires Saint Luc
Brussels
1200
Belgium
Jolimont
Haine-Saint-Paul
7100
Belgium
Az Groeninge
Kortrijk
8500
Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège
4000
Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas
9100
Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk
2610
Belgium
Fundacao Pio XII
Barretos
14784-400
Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
30150-221
Brazil
Liga Paranaense de Combate ao Cancer
Curitiba
81520 060
Brazil
Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro
Fortaleza
60170-170
Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro
22250 905
Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro
22775 001
Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
FG006
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
FG007
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
FG0004 subjects
FG0013 subjects
FG00211 subjects
FG00312 subjects
FG0043 subjects
FG0053 subjects
FG00644 subjects
FG00745 subjects
Treated (Treated Analysis Set)
FG0004 subjects
FG0013 subjects
FG00211 subjects
FG00312 subjects
FG0043 subjects
FG0053 subjects
FG00643 subjects
FG00744 subjects
COMPLETED
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0033 subjects
FG0042 subjects
FG0052 subjects
FG00621 subjects
FG00717 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0039 subjects
FG0041 subjects
FG0051 subjects
FG00623 subjects
FG00728 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Ongoing
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0038 subjects
FG004
Randomized but not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety analysis set was defined as all participants who had received at least one dose of study drug.
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
BG006
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
BG007
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0013
BG00211
BG00312
BG0043
BG0053
BG00643
BG00744
BG008123
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00072.8± 6.5
BG00166.7± 9.07
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
BELARUS
Title
Measurements
BG0000
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
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Treated analysis set included all participants who had received at least one dose of study drug.
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
Treated analysis set included all participants who had received at least one dose of study drug.
Posted
Number
Percentage of Participants
From Day 1 up to 36 months
ID
Title
Description
OG000
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
OG001
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Primary
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
Treated analysis set included all participants who had received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 up to 36 months
ID
Title
Description
OG000
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
OG001
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Secondary
Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 2: Number of Participants With Abnormal Laboratory Values
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 2: Duration of Response (DoR)
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 2: Time to Response (TTR)
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 2: Progression-free Survival (PFS)
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Secondary
Phase 2: Overall Survival (OS)
Not Posted
Jun 2026
Up to 6 years 1 month
Participants
Time Frame
Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Description
Treated analysis set included all participants who had received at least one dose of study drug.
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
2
3
1
3
3
3
EG006
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
21
43
22
43
43
43
EG007
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
17
44
19
44
43
44
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG0030 affected12 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected43 at risk
EG0070 affected44 at risk
Disseminated Intravascular Coagulation
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Maculopathy
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Punctate Keratitis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Serous Retinal Detachment
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Ulcerative Keratitis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Intestinal Mass
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Large Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Large Intestine Perforation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Asthenia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Abdominal Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cholecystitis Infective
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Epididymitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Febrile Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Herpes Ophthalmic
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Peritonitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pyelonephritis Chronic
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Type 1 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Mobility Decreased
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Colorectal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Infected Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Tumour Perforation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Erythema Nodosum
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hypovolaemic Shock
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0022 affected11 at risk
EG0033 affected12 at risk
EG0043 affected3 at risk
EG0052 affected3 at risk
EG00616 affected43 at risk
EG00717 affected44 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Sinus Bradycardia
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0022 affected11 at risk
EG003
Cataract
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0022 affected11 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Conjunctival Hyperaemia
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Detachment of Macular Retinal Pigment Epithelium
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Detachment of Retinal Pigment Epithelium
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Eye Discharge
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Eye Pain
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Eyelid Oedema
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Keratitis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Lacrimal Disorder
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Macular Detachment
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Photophobia
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Posterior Capsule Opacification
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Serous Retinal Detachment
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Trichiasis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Ulcerative Keratitis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Uveitis
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Vision Blurred
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Visual Impairment
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Vitreous Floaters
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0024 affected11 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0021 affected11 at risk
EG003
Anal Fissure
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Anal Inflammation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Anal Ulcer
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected3 at risk
EG0025 affected11 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0029 affected11 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0012 affected3 at risk
EG0026 affected11 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Gingival Disorder
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Mallory-Weiss Syndrome
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0024 affected11 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0013 affected3 at risk
EG0023 affected11 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0022 affected11 at risk
EG003
Asthenia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0024 affected11 at risk
EG003
Chills
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Face Oedema
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Localised Oedema
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Malaise
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Xerosis
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Autoimmune Hepatitis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Gallbladder Polyp
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hepatobiliary Disease
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dermatophytosis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Genital Herpes
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Herpes Virus Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Klebsiella Bacteraemia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Laryngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Lip Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nail Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0021 affected11 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Perirectal Abscess
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Skin Bacterial Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Skin Candida
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Strongyloidiasis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Vaginal Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Corneal Abrasion
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Persistent Corneal Epithelial Defect
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0024 affected11 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0023 affected11 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Blood Calcium Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Blood Parathyroid Hormone Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Blood Urea Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Lipase Increased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0024 affected11 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected3 at risk
EG0022 affected11 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0023 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0023 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected3 at risk
EG0028 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0022 affected11 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected3 at risk
EG0020 affected11 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cardiac Myxoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Ageusia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Disturbance in Attention
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0012 affected3 at risk
EG0022 affected11 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Mental Impairment
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Peripheral Sensorimotor Neuropathy
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Adjustment Disorder
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Mixed Anxiety and Depressive Disorder
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nephropathy Toxic
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Urinary Tract Pain
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Scrotal Dermatitis
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Scrotal Oedema
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Testicular Cyst
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Vulvovaginal Pruritus
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0024 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Lung Infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected3 at risk
EG0024 affected11 at risk
EG003
Dermal Cyst
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected3 at risk
EG0022 affected11 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Hand Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Lichen Planus
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Lichen Sclerosus
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nail Discolouration
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Nail Dystrophy
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0024 affected11 at risk
EG003
Nail Ridging
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Nail Toxicity
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0024 affected11 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected3 at risk
EG0023 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0022 affected11 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0022 affected11 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0021 affected11 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Embolism
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0020 affected11 at risk
EG003
Peripheral Venous Disease
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected11 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
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.