Study of REGN2810 in Patients With Advanced Cutaneous Squ... | NCT02760498 | Trialant
NCT02760498
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
May 28, 2025Actual
Enrollment
432Actual
Phase
Phase 2
Conditions
Advanced Cutaneous Squamous Cell Carcinoma
Interventions
cemiplimab
Countries
United States
Australia
Brazil
France
Germany
Greece
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT02760498
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R2810-ONC-1540
Secondary IDs
ID
Type
Description
Link
2016-000105-36
EudraCT Number
Brief Title
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official Title
A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 7, 2016Actual
Primary Completion Date
Oct 18, 2023Actual
Completion Date
Oct 18, 2023Actual
First Submitted Date
Apr 8, 2016
First Submission Date that Met QC Criteria
Apr 29, 2016
First Posted Date
May 3, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 16, 2024
Results First Submitted that Met QC Criteria
Dec 6, 2024
Results First Posted Date
Dec 11, 2024Actual
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
May 8, 2025
Last Update Posted Date
May 28, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cutaneous Squamous Cell Carcinoma
Keywords
Metastatic CSCC
Unresectable locally advanced CSCC
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
432Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W
Experimental
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Drug: cemiplimab
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W
Experimental
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Drug: cemiplimab
Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W
Experimental
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Drug: cemiplimab
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W
Experimental
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
Drug: cemiplimab
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W
Experimental
Participants received a single subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cemiplimab
Drug
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W
Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) by Independent Central Review
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) <1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Up to 108 weeks
Secondary Outcomes
Measure
Description
Time Frame
ORR by Investigator Assessment
ORR was defined as percentage of participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm <1 cm. -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
At least 1 measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Adequate bone marrow function
Adequate renal function
Adequate hepatic function
Archived or newly obtained tumor material
Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6)
Surgical or radiological treatment of lesions contraindicated
Key Exclusion Criteria:
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
Prior treatment with an agent that blocks the PD-1/PD-L1pathway
Prior treatment with a BRAF inhibitor
Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
Untreated brain metastasis(es) that may be considered active
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
History of non-infectious pneumonitis within the last 5 years
Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
Known allergy to doxycycline or tetracycline
Patients with a history of solid organ transplant
Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable
Other protocol-defined inclusion/exclusion criteria apply
Hughes BGM, Guminski A, Bowyer S, Migden MR, Schmults CD, Khushalani NI, Chang ALS, Grob JJ, Lewis KD, Ansstas G, Day F, Ladwa R, Stein BN, Munoz Couselo E, Meier F, Hauschild A, Schadendorf D, Basset-Seguin N, Modi B, Dalac-Rat S, Dunn LA, Flatz L, Mortier L, Guegan S, Heinzerling LM, Mehnert JM, Trabelsi S, Soria-Rivas A, Stratigos AJ, Ulrich C, Wong DJ, Beylot-Barry M, Bossi P, Buges Sanchez C, Chandra S, Robert C, Russell JS, Silk AW, Booth J, Yoo SY, Seebach F, Lowy I, Fury MG, Rischin D. A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6. J Am Acad Dermatol. 2025 Jan;92(1):68-77. doi: 10.1016/j.jaad.2024.06.108. Epub 2024 Sep 7.
A total of 432 participants with advanced cutaneous squamous cell carcinoma (CSCC) (metastatic CSCC [mCSCC] or locally advanced CSCC [laCSCC]) were enrolled.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
FG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
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
Sep 9, 2021
Oct 16, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
New Zealand
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: cemiplimab
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W
Experimental
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Drug: cemiplimab
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W
REGN2810
Libtayo
Up to 108 weeks
Duration of Response (DOR) by Independent Central Review
DOR was measured from the time measurement criteria were first met for CR/PR, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
DOR by Investigator Assessment
DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Progression-Free Survival (PFS) by Independent Central Review
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
PFS by Investigator Assessment
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Overall Survival (OS)
OS was measured from start of treatment until death due to any cause.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Complete Response (CR) Rate by Independent Central Review
CR rate was defined as percentage of participants with BOR of CR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm <1 cm. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions.
Up to 108 weeks
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.
Baseline, Up to Cycle 12 Day 1 (Week 89)
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Up to 108 weeks plus 105 days (5 half-lives)
Peak Concentration (Cmax) of Cemiplimab
Up to approximately 43 months
Trough Concentration (Ctrough) of Cemiplimab
Up to approximately 43 months
Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies
Up to approximately 43 months
ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays
ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Up to 108 weeks
DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays
DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays
PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Phoenix
Arizona
85054
United States
City of Hope Hospital
Duarte
California
91010
United States
University of California, Los Angeles
Los Angeles
California
90095
United States
Stanford University
Redwood City
California
94063
United States
University of California, San Diego
San Diego
California
92161
United States
University of Colorado, Denver
Aurora
Colorado
80045
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach
Florida
33140
United States
H. Lee Moffitt Cancer Center
Tampa
Florida
33612
United States
Northwestern University
Chicago
Illinois
60611
United States
Norton Cancer Institute
Louisville
Kentucky
40202
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02130
United States
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
48201
United States
St. Louis University
St Louis
Missouri
63104
United States
Washington University in St. Louis
St Louis
Missouri
63110
United States
Nebraska Methodist Hospital
Omaha
Nebraska
68114
United States
New York University
New York
New York
10016
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10021
United States
University of Rochester Medical Center
Rochester
New York
14623
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
St. Luke's Hematology Oncology Specialists
Easton
Pennsylvania
18015
United States
Penn State Hershey Medical Center
Hershey
Pennsylvania
17033
United States
Dermatology and Laser Center of Charleston
Charleston
South Carolina
29407
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
The Canberra Hospital
Garran
Australian Capital Territory
Australia
Gosford Hospital
Gosford
New South Wales
Australia
Royal North Shore Hospital
St Leonards
New South Wales
2065
Australia
Calvary Mater Newcastle
Waratah
New South Wales
Australia
Royal Brisbane & Women's Hospital
Herston
Queensland
4029
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
Australia
Adelaide Cancer Centre
Kurralta Park
South Australia
5037
Australia
Peter MacCallum Cancer Centre
Melbourne
Victoria
3000
Australia
Border Medical Oncology
Wodonga
Victoria
Australia
Sir Charles Gairdner Hospital
Nedlands
Western Australia
6009
Australia
Hospital de Clinicas de Porto Alegre
Porto Alegre
Rio Grande do Sul
Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba
Brazil
Fundação São Francisco Xavier-Hospital Márcio Cunha
Ipatinga
Brazil
Animi
Lages
Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center
São Paulo
Brazil
Instituto do Cancer do Estado de São Paulo ICESP
São Paulo
Brazil
Hôpital Claude Huriez
Lille
Nord
59037
France
Hopital Avicenne
Bobigny
93000
France
Hôpital Saint-André
Bordeaux
33000
France
CHU Dijon Bourgogne
Dijon
21079
France
CHRU Grenoble
Grenoble
38043
France
Hopitaux de La Timone
Marseille
13009
France
Centre Hospitalier Universitaire de Nantes
Nantes
44093
France
Hopital Cochin
Paris
75014
France
Hôpital Saint Louis
Paris
75475
France
Centre Hospitalier Lyon Sud
Pierre-Bénite
69495
France
Institut Gustave Roussy
Villejuif
94085
France
Universitätsklinikum Tübingen
Tübingen
Baden-Wurttemberg
72076
Germany
LMU Klinikum der Universität München
Munich
Bavaria
80337
Germany
Medizinische Hochschule Hannover
Hanover
Lower Saxony
30625
Germany
Universitätsklinikum Essen
Essen
North Rhine-Westphalia
45147
Germany
Universitätsklinikum Carl Gustav Carus
Dresden
Saxony
01307
Germany
Universitatsklinikum Schleswig-Holstein
Kiel
Schleswig-Holstein
24105
Germany
Charitè Campus Mitte
Berlin
10117
Germany
SRH Wald-Klinikum Gera
Gera
07548
Germany
Andreas Sygros Hosptial-University of Athen
Athens
16121
Greece
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples
Campania
Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padova
Veneto
Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia
Italy
Ospedale San Salvatore
L’Aquila
Italy
Istituto Europeo Di Oncologia
Milan
Italy
Fondazione Policlinico Universitario A Gemelli
Roma
Italy
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat
Barelona
08908
Spain
Hospital Clinic de Barcelona
Barcelona
Catalonia
08036
Spain
Hospital Universitario Vall d'Hebron
Barcelona
08035
Spain
Hospital Universitario Germans Trias i Pujol
Barcelona
08916
Spain
C.H. Regional Reina Sofia - PPDS
Córdoba
14004
Spain
Hospital Universitario Ramon y Cajal
Madrid
28034
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid
28040
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Universitario Marques de Valdecilla
Santander
39008
Spain
Fundacion Instituto Valenciano de Oncología
Valencia
46009
Spain
Derived
Rischin D, Hughes BGM, Basset-Seguin N, Schadendorf D, Bowyer S, Trabelsi Messai S, Meier F, Eigentler TK, Casado Echarren V, Stein B, Beylot-Barry M, Dalac S, Dreno B, Migden MR, Hauschild A, Schmults CD, Lim AM, Yoo SY, Paccaly AJ, Papachristos A, Nguyen JH, Okoye E, Seebach F, Booth J, Lowy I, Fury MG, Guminski A. High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma. J Immunother Cancer. 2024 Mar 11;12(3):e008325. doi: 10.1136/jitc-2023-008325.
Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8):e002757. doi: 10.1136/jitc-2021-002757.
Paccaly AJ, Migden MR, Papadopoulos KP, Yang F, Davis JD, Rippley RK, Lowy I, Fury MG, Stankevich E, Rischin D. Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis. Adv Ther. 2021 May;38(5):2365-2378. doi: 10.1007/s12325-021-01638-5. Epub 2021 Mar 25.
Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
FG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
FG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
FG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
FG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
FG00059 subjects
FG00178 subjects
FG00256 subjects
FG00363 subjects
FG0049 subjects
FG005167 subjects
Received at Least 1 Dose of Study Drug
FG00059 subjects
FG00178 subjects
FG00256 subjects
FG00363 subjects
FG0049 subjects
FG005165 subjects
Completed Treatment
FG00024 subjects
FG00120 subjects
FG00222 subjects
FG00327 subjects
FG0045 subjects
FG00550 subjects
COMPLETED
Completed Study
FG00019 subjects
FG00128 subjects
FG00222 subjects
FG00324 subjects
FG0043 subjects
FG00564 subjects
NOT COMPLETED
FG00040 subjects
FG00150 subjects
FG00234 subjects
FG00339 subjects
FG0046 subjects
FG005103 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0056 subjects
Death
FG0007 subjects
FG0015 subjects
FG0025 subjects
FG0037 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-compliance with study drug
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant decision
FG0001 subjects
FG0014 subjects
FG0022 subjects
FG0032 subjects
FG004
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Physician Decision
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0034 subjects
FG004
Disease progression
FG00021 subjects
FG00119 subjects
FG00220 subjects
FG00318 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0017 subjects
FG0025 subjects
FG0031 subjects
FG004
Other than specified
FG0001 subjects
FG0016 subjects
FG0020 subjects
FG0033 subjects
FG004
Not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Full Analysis Set (FAS) included all enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
BG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
BG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
BG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
BG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
BG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00059
BG00178
BG00256
BG00363
BG0049
BG005167
BG006432
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
< 65 years
Title
Measurements
BG00016
BG00119
BG00214
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
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
Overall Response Rate (ORR) by Independent Central Review
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) <1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
The Full Analysis Set (FAS) included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this analysis.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 108 weeks
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG00050.8(37.5 to 64.1)
OG00144.9(33.6 to 56.6)
OG00246.4(33.0 to 60.3)
OG003
Secondary
ORR by Investigator Assessment
ORR was defined as percentage of participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm <1 cm. -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
The FAS included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 108 weeks
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Secondary
Duration of Response (DOR) by Independent Central Review
DOR was measured from the time measurement criteria were first met for CR/PR, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR who were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Secondary
DOR by Investigator Assessment
DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Secondary
Progression-Free Survival (PFS) by Independent Central Review
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Secondary
PFS by Investigator Assessment
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Secondary
Overall Survival (OS)
OS was measured from start of treatment until death due to any cause.
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Secondary
Complete Response (CR) Rate by Independent Central Review
CR rate was defined as percentage of participants with BOR of CR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm <1 cm. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions.
The FAS included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 108 weeks
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.
The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number Analyzed" is the number evaluable at each time point. Only Groups 1, 2, 3, and 4 were planned for this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Up to Cycle 12 Day 1 (Week 89)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Secondary
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
The Safety Analysis Set (SAF) included all enrolled participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
Up to 108 weeks plus 105 days (5 half-lives)
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Secondary
Peak Concentration (Cmax) of Cemiplimab
The Pharmacokinetic (PK) analysis set included all participants who had received cemiplimab and had at least 1 qualified (non-missing) post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified point.
Posted
Mean
Standard Deviation
milligram per liter (mg/L)
Up to approximately 43 months
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Secondary
Trough Concentration (Ctrough) of Cemiplimab
The PK analysis set included all participants who had received cemiplimab and had at least 1 qualified (non-missing) post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified point.
Posted
Mean
Standard Deviation
mg/L
Up to approximately 43 months
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Secondary
Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies
The Anti-drug Antibody (ADA) population for cemiplimab included all treated participants who had at least 1 postdose ADA result for cemiplimab.
Posted
Count of Participants
Participants
Up to approximately 43 months
ID
Title
Description
OG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Secondary
ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays
ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' is the number of participants who are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 108 weeks
ID
Title
Description
OG000
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
Secondary
DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays
DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
Secondary
PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays
PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants who are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
ID
Title
Description
OG000
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG000
Time Frame
From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
Description
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
27
59
24
59
56
59
EG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
19
78
28
78
75
78
EG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
26
56
23
56
49
56
EG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
23
63
35
63
59
63
EG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
2
9
2
9
9
9
EG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
59
165
85
165
147
165
EG006
Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W
Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 350 mg SC Q3W for up to a total (IV + SC) of 108 weeks.
2
12
4
12
9
12
EG007
Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W
Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 1050 mg SC Q6W for up to a total (IV + SC) of 108 weeks.
0
7
1
7
5
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected59 at risk
EG0016 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG0033 events3 affected63 at risk
EG0040 events0 affected9 at risk
EG0059 events7 affected165 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected7 at risk
Cellulitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0006 events4 affected59 at risk
EG0012 events2 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Sepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0012 events2 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Encephalitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Influenza
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Skin infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Wound infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Abscess bacterial
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cystitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Device related infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Endocarditis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Groin infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Localised infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Meningitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Septic shock
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Viral infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0006 events4 affected59 at risk
EG0015 events4 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0002 events1 affected59 at risk
EG0012 events2 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events2 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0022 events1 affected56 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Soft tissue necrosis
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events2 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Follicular lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events2 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Death
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
General physical health deterioration
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0022 events1 affected56 at risk
EG003
Inflammation
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Peripheral swelling
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Sudden death
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Syncope
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cardiac flutter
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events2 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Overflow diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Influenza A virus test positive
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
General physical condition abnormal
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0022 events1 affected56 at risk
EG003
Lipase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Troponin I increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0012 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0011 events1 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Arterial haemorrhage
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Immune-mediated hypophysitis
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0022 events2 affected56 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Device occlusion
Product Issues
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Depression
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0022 events2 affected56 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0021 events1 affected56 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG00029 events17 affected59 at risk
EG00142 events23 affected78 at risk
EG00218 events13 affected56 at risk
EG00323 events17 affected63 at risk
EG0043 events3 affected9 at risk
EG00558 events39 affected165 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected7 at risk
Nausea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG00017 events14 affected59 at risk
EG00125 events20 affected78 at risk
EG00212 events12 affected56 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG00112 events12 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0008 events6 affected59 at risk
EG00113 events11 affected78 at risk
EG0028 events8 affected56 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG00012 events10 affected59 at risk
EG00111 events10 affected78 at risk
EG00211 events10 affected56 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0014 events4 affected78 at risk
EG0024 events3 affected56 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events5 affected59 at risk
EG0010 events0 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Poor dental condition
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events4 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG00018 events15 affected59 at risk
EG00141 events34 affected78 at risk
EG00219 events17 affected56 at risk
EG003
Chills
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0017 events6 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0018 events6 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Facial pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0015 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected59 at risk
EG0014 events4 affected78 at risk
EG0026 events6 affected56 at risk
EG003
Asthenia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Catheter site rash
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
General physical health deterioration
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Infusion site extravasation
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Injection site discomfort
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Terminal agitation
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG00014 events11 affected59 at risk
EG00129 events23 affected78 at risk
EG0028 events7 affected56 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected59 at risk
EG00115 events12 affected78 at risk
EG0027 events7 affected56 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG00018 events11 affected59 at risk
EG00115 events11 affected78 at risk
EG00213 events10 affected56 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0006 events6 affected59 at risk
EG0019 events8 affected78 at risk
EG0024 events4 affected56 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG00011 events9 affected59 at risk
EG00113 events8 affected78 at risk
EG0028 events7 affected56 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0024 events3 affected56 at risk
EG003
Tumour pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected59 at risk
EG00110 events8 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0009 events8 affected59 at risk
EG0017 events7 affected78 at risk
EG0024 events4 affected56 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0019 events7 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG00110 events7 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events3 affected59 at risk
EG0018 events7 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0016 events6 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0015 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG00016 events12 affected59 at risk
EG00112 events11 affected78 at risk
EG00213 events10 affected56 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0007 events5 affected59 at risk
EG0018 events8 affected78 at risk
EG0026 events6 affected56 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0017 events6 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events4 affected59 at risk
EG0016 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected59 at risk
EG0017 events5 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 events5 affected59 at risk
EG00110 events10 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 events4 affected59 at risk
EG0018 events8 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Weight decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0017 events7 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0016 events6 affected78 at risk
EG0024 events4 affected56 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0006 events4 affected59 at risk
EG0015 events5 affected78 at risk
EG0025 events5 affected56 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0014 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 events4 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Red blood cell count increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG00012 events11 affected59 at risk
EG00118 events16 affected78 at risk
EG0025 events5 affected56 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0007 events6 affected59 at risk
EG0016 events6 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0014 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0007 events6 affected59 at risk
EG0014 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0006 events5 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events5 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG00013 events6 affected59 at risk
EG00112 events9 affected78 at risk
EG0026 events5 affected56 at risk
EG003
Wound infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0006 events4 affected59 at risk
EG0017 events7 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG00013 events6 affected59 at risk
EG00111 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0015 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Skin infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0007 events4 affected59 at risk
EG0015 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
COVID-19
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Infected cyst
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Nail infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0009 events5 affected59 at risk
EG0010 events0 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0005 events5 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0009 events7 affected59 at risk
EG00113 events8 affected78 at risk
EG0028 events8 affected56 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0015 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0006 events3 affected59 at risk
EG00115 events10 affected78 at risk
EG0025 events3 affected56 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0016 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG00010 events5 affected59 at risk
EG0016 events4 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG00012 events11 affected59 at risk
EG0018 events7 affected78 at risk
EG0024 events3 affected56 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0009 events8 affected59 at risk
EG0015 events5 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events4 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0025 events4 affected56 at risk
EG003
Syncope
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0006 events6 affected59 at risk
EG0019 events9 affected78 at risk
EG0027 events7 affected56 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Eye swelling
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0014 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0015 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Dry eye
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0005 events5 affected59 at risk
EG0014 events4 affected78 at risk
EG0026 events4 affected56 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0015 events4 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0018 events8 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0023 events3 affected56 at risk
EG003
Depression
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0005 events5 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0006 events6 affected59 at risk
EG00111 events7 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hot flush
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0024 events4 affected56 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected59 at risk
EG0010 events0 affected78 at risk
EG0020 events0 affected56 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG00363
OG004167
Title
Denominators
Categories
Title
Measurements
OG00050.8(37.5 to 64.1)
OG00156.4(44.7 to 67.6)
OG00255.4(41.5 to 68.7)
OG00363.5(50.4 to 75.3)
OG00452.7(44.8 to 60.5)
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00030
OG00135
OG00226
OG00339
OG00479
Title
Denominators
Categories
Title
Measurements
OG000NA(20.7 to NA)Not reached due to insufficient number of events
OG00141.9(20.5 to 54.6)
OG00241.3(40.8 to 46.3)
OG003NA(30.5 to NA)Not reached due to insufficient number of events
OG00431.6(29.5 to NA)Not reached due to insufficient number of events
OG001
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00030
OG00144
OG00231
OG00340
OG00488
Title
Denominators
Categories
Title
Measurements
OG000NA(30.7 to NA)Not reached due to insufficient number of events
OG00141.9(NA to NA)Not reached due to insufficient number of events
OG00244.2(25.4 to 44.2)
OG003NA(27.1 to NA)Not reached due to insufficient number of events
OG004NA(29.5 to NA)Not reached due to insufficient number of events
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG00363
OG004165
Title
Denominators
Categories
Title
Measurements
OG00018.4(7.3 to 53.2)
OG00118.5(11.1 to 43.8)
OG00221.7(3.8 to 43.3)
OG00332.2(16.6 to NA)Not reached due to insufficient number of events
OG00416.6(12.4 to 31.5)
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG00363
OG004165
Title
Denominators
Categories
Title
Measurements
OG00016.6(7.3 to NA)Not reached due to insufficient number of events
OG00132.5(17.1 to 43.8)
OG00215.2(4.1 to 43.0)
OG00325.3(8.2 to NA)Not reached due to insufficient number of events
OG00416.5(10.3 to 31.3)
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG00363
OG004165
Title
Denominators
Categories
Title
Measurements
OG00057.7(29.3 to NA)Not reached due to insufficient number of events
OG001NA(58.3 to NA)Not reached due to insufficient number of events
OG00248.4(29.5 to NA)Not reached due to insufficient number of events
OG003NA(28.6 to NA)Not reached due to insufficient number of events
OG004NA(NA to NA)Not reached due to insufficient number of events
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG00363
OG004167
Title
Denominators
Categories
Title
Measurements
OG00020.3(11.0 to 32.8)
OG00112.8(6.3 to 22.3)
OG00219.6(10.2 to 32.4)
OG00322.2(12.7 to 34.5)
OG00410.8(6.5 to 16.5)
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
Units
Counts
Participants
OG00044
OG00168
OG00238
OG00354
Title
Denominators
Categories
Cycle 2 Day 1 (C2D1)
ParticipantsOG00042
ParticipantsOG00160
ParticipantsOG00234
ParticipantsOG00352
Title
Measurements
OG0000.00± 21.464
OG0015.56± 18.895
OG0026.86± 19.621
OG003
C3D1
ParticipantsOG00037
ParticipantsOG00155
ParticipantsOG00230
ParticipantsOG00343
C4D1
ParticipantsOG00036
ParticipantsOG00139
ParticipantsOG00229
ParticipantsOG00338
C5D1
ParticipantsOG00036
ParticipantsOG00141
ParticipantsOG00227
ParticipantsOG00336
C6D1
ParticipantsOG00031
ParticipantsOG00144
ParticipantsOG00226
ParticipantsOG00333
C7D1
ParticipantsOG00032
ParticipantsOG00140
ParticipantsOG00212
ParticipantsOG00315
C8D1
ParticipantsOG00029
ParticipantsOG00133
ParticipantsOG00211
ParticipantsOG00315
C9D1
ParticipantsOG00026
ParticipantsOG00129
ParticipantsOG00210
ParticipantsOG00313
C10D1
ParticipantsOG00027
ParticipantsOG00123
ParticipantsOG0029
ParticipantsOG00310
C11D1
ParticipantsOG00025
ParticipantsOG00119
ParticipantsOG00210
ParticipantsOG0039
C12D1
ParticipantsOG00024
ParticipantsOG00117
ParticipantsOG0029
ParticipantsOG0039
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
OG002
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00059
OG00178
OG00256
OG00363
OG0049
OG005165
Title
Denominators
Categories
Title
Measurements
OG00059
OG00178
OG00255
OG00363
OG0049
OG005163
OG003
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00058
OG00175
OG00252
OG00362
OG0049
OG005162
Title
Denominators
Categories
After the First Dose
ParticipantsOG00058
ParticipantsOG00175
ParticipantsOG00252
ParticipantsOG00362
ParticipantsOG0049
ParticipantsOG005162
Title
Measurements
OG000108± 147
OG00184.1± 105
OG002132± 203
OG003
At Steady State
ParticipantsOG00038
ParticipantsOG00158
ParticipantsOG00233
ParticipantsOG00341
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00053
OG00171
OG00246
OG00358
OG0049
OG005143
Title
Denominators
Categories
After the First Dose
ParticipantsOG00053
ParticipantsOG00171
ParticipantsOG00246
ParticipantsOG00358
ParticipantsOG0049
ParticipantsOG005142
Title
Measurements
OG00021.5± 7.12
OG00126.3± 14.3
OG00233.6± 32.1
OG003
At Steady State
ParticipantsOG00038
ParticipantsOG00158
ParticipantsOG00234
ParticipantsOG00344
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
OG004
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
OG005
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Units
Counts
Participants
OG00050
OG00166
OG00241
OG00350
OG0048
OG005133
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0055
OG000
96
Title
Denominators
Categories
PD-L1 < 1%
ParticipantsOG00037
Title
Measurements
OG00040.5(24.8 to 57.9)
PD-L1 >= 1%
ParticipantsOG00059
Title
Measurements
OG00049.2(35.9 to 62.5)
OG00044
Title
Denominators
Categories
PD-L1 < 1%
ParticipantsOG00015
Title
Measurements
OG00031.6(12.6 to NA)Not reached due to insufficient number of events
PD-L1 >= 1%
ParticipantsOG00029
Title
Measurements
OG000NA(NA to NA)Not reached due to insufficient number of events
96
Title
Denominators
Categories
PD-L1 < 1%
ParticipantsOG00037
Title
Measurements
OG00010.7(3.0 to 15.3)
PD-L1 >= 1%
ParticipantsOG00059
Title
Measurements
OG00016.6(4.0 to NA)Not reached due to insufficient number of events