REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma
Official Title
A Safety and Pharmacokinetic Study of Single Agent REGN2810 in Pediatric Patients With Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Trial of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Newly Diagnosed High-Grade Glioma, or Recurrent High-Grade Glioma
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Apr 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor Decision
Expanded Access Info
No
Start Date
Sep 24, 2018Actual
Primary Completion Date
May 10, 2023Actual
Completion Date
May 10, 2023Actual
First Submitted Date
Sep 17, 2018
First Submission Date that Met QC Criteria
Sep 28, 2018
First Posted Date
Oct 1, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 7, 2024
Results First Submitted that Met QC Criteria
Oct 1, 2024
Results First Posted Date
Oct 9, 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
Apr 4, 2025
Last Update Posted Date
Apr 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Pacific Pediatric Neuro-Oncology Consortium
OTHER
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
Phase 1:
To confirm the safety and anticipated recommended phase 2 dose (RP2D) of REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors
To characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or CNS tumors
Phase 2 (Efficacy Phase):
To confirm the safety and anticipated RP2D of REGN2810 to be given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG)
To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed high-grade glioma (HGG)
To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with re-irradiation in patients with recurrent HGG
To assess PK of REGN2810 in pediatric patients with newly diagnosed DIPG, newly diagnosed HGG, or recurrent HGG when given in combination with radiation
To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at 12 months (OS12) among patients with newly diagnosed DIPG
To assess anti-tumor activity of REGN2810 in combination with radiation in improving progression-free survival at 12 months (PFS12) among patients with newly diagnosed HGG
To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at OS12 among patients with recurrent HGG
Detailed Description
Not provided
Conditions Module
Conditions
Relapsed Solid Tumor
Refractory Solid Tumor
Relapsed Central Nervous System Tumor
Refractory Central Nervous System Tumor
Diffuse Intrinsic Pontine Glioma
High Grade Glioma
Keywords
Newly Diagnosed
Recurrent
Refractory
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1
Experimental
Patients in both the Solid Tumor Cohort and the CNS Cohort will receive cemiplimab monotherapy. Each Cohort will have 2 subgroups by age (0 to <12 years, 12 to <18 years).
Drug: cemiplimab (monotherapy)
Efficacy with Newly Diagnosed DIPG
Experimental
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
Drug: cemiplimab (maintenance)
Radiation: Conventional or hypofractionated
Efficacy with Newly Diagnosed HGG
Experimental
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
Drug: cemiplimab (maintenance)
Radiation: Conventional or hypofractionated
Efficacy with Recurrent HGG
Experimental
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
Drug: cemiplimab (maintenance)
Radiation: Re-irradiation
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cemiplimab (monotherapy)
Drug
To be administered intravenously as monotherapy in Phase 1
Phase 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Treatment-emergent Adverse Events (TEAEs)
TEAEs are AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occur during the post-treatment period but prior to initiation of other anticancer therapy. Number of TEAEs reported.
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs
NCI CTCAE version 4.0 was utilized for AE grading of severity: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). Number of NCI grade 3/4/5 Treatment-Emergent Adverse Events (AEs) reported
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs)
Number of sponsor-identified irAEs (all grades) reported.
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs
Number of severe treatment-emergent sponsor-identified irAEs reported.
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Treatment-emergent AEs of Special Interest (AESI)
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR)
ORR was defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR), as determined per standard criteria between the date of first study treatment and the date of the first objectively documented progression or the date of receiving another anti-cancer systemic therapy, whichever came first. Clopper-Person exact confidence interval
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Age 0 to <18 years of age (Phase 1)
Age ≥3 and ≤25 years of age (Efficacy Phase)
Karnofsky performance status ≥50 (patients >16 years) or Lansky performance status ≥50 (patients ≤ 16 years)
Life expectancy >8 weeks
Adequate Bone Marrow Function
Adequate Renal Function
Adequate Liver Function
Adequate Neurologic Function
Key Exclusion Criteria:
Patients with bulky metastatic disease of the CNS causing Uncal herniation or symptomatic midline shift, significant, symptomatic mass effect, or uncontrolled neurological symptoms such as seizures or altered mental status
Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of >2 lobes
Patients who are receiving any other investigational anticancer agent(s)
Patients on greater than dexamethasone 0.1 mg/kg/day (maximum 4 mg/day) or equivalent dose in alternate corticosteroid, or actively undergoing corticosteroid dose escalation in the last 7 days
Patients with a history of allogeneic stem cell transplant
Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
25 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trial Management
Regeneron Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Children's Hospital Los Angeles (CHLA)
Los Angeles
California
90054
United States
Rady Children's Hospital
References Module
Citations
Not provided
See Also Links
Label
URL
A Plain Language Summary is available on TrialSummaries.com
65 participants were screened; 57 participants were enrolled and had received at least 1 dose of REGN2810 at time of study termination (Sponsor decision)
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
FG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 19, 2020
May 7, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
REGN2810
Libtayo
cemiplimab (maintenance)
Drug
To be administered intravenously in combination with radiation and then used as maintenance therapy
Efficacy with Newly Diagnosed DIPG
Efficacy with Newly Diagnosed HGG
Efficacy with Recurrent HGG
REGN2810
Libtayo
Conventional or hypofractionated
Radiation
Combined with cemiplimab IV administration
Efficacy with Newly Diagnosed DIPG
Efficacy with Newly Diagnosed HGG
Re-irradiation
Radiation
Combined with cemiplimab IV administration
Efficacy with Recurrent HGG
AEs of special interest (AESI) are AEs required to be monitored, documented, and managed in a pre-specified manner as described in the protocol. Number of treatment-emergent AESI reported.
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of NCI Grade 3/4/5 Treatment-emergent AESI
Number of NCI grade 3/4/5 treatment-emergent AESI reported
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Participants With Any TEAE Resulting in Death
Number of participants with any TEAE resulting in death reported
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
Number of participants with new or worsened laboratory abnormalities (NCI-CTCAE All Grades) reported in Hematology, Electrolytes, Liver, Chemistry; Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE).
Up to 36 months
Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1)
Number of participants who developed dose limiting toxicities (DLTs) in phase 1 reported
Baseline to 28 days
Number of Participants Who Developed DLTs (Efficacy Phase)
Up to 4 weeks post radiation therapy
Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum
Up to 24 months
Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum
Ctrough (trough concentration) of functional cemiplimab in serum reported.
Up to Week 16
Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum
Cmax (peak concentration) of functional cemiplimab in serum reported.
Up to Week 16
Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum
Up to 24 months
Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG)
PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined per Response Assessment in Neuro-Oncology (RANO)/Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria, or death due to any cause.
At 12 months
Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG)
OS was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last date that participant was documented to be alive. 95% CI is based on Kaplan-Meier method.
Up to 12 months
Approximately 24 months
Number of Participants With Anti-REGN2810 Antibodies (ADA)
ADA status classified as: Positive; Pre-existing (baseline [BL] sample positive & all post BL ADA titers reported as < 9-fold BL titer value); Negative (all samples negative); ADA positive: Treatment-boosted (positive result at BL with ≥1 post BL titer result ≥9-fold BL titer value); Treatment-emergent (TE) (negative result or missing result at BL with ≥1 positive post BL result); TE: Persistent (positive result detected in ≥2 consecutive post BL samples separated by ≥ a 12/16-week post BL period with no ADA-negative results in-between, regardless of any missing samples; Indeterminate (positive result in last collection, regardless of any missing samples); Transient (not persistent or indeterminate, regardless of any missing samples)
1st follow-up visit, approximately 25 months
San Diego
California
92123
United States
UCSF Benioff Children's Hospital
San Francisco
California
94158
United States
Children's National Health System (Children's National Medical Center)
Washington D.C.
District of Columbia
20010
United States
University of Florida- Neurosurgery
Gainesville
Florida
32610
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Illinois
60611
United States
Johns Hopkins - Pediatric Oncology
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Dana Farber Cancer Institute/ Boston Children's Hospital
Boston
Massachusetts
02215
United States
C. S. Mott/University of Michigan
Ann Arbor
Michigan
48109
United States
Children's Hospitals and Clinics of Minnesota
Minneapolis
Minnesota
55404
United States
University of Minnesota / Masonic Cancer Center
Minneapolis
Minnesota
55455
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Nationwide Children's Hospital
Columbus
Ohio
43205
United States
Oregon Health & Science University (OHSU) - Doernbecher Children's Hospital
Portland
Oregon
97239
United States
The Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
19104
United States
St. Jude Children's Research Hospital
Memphis
Tennessee
38105
United States
Texas Children's Cancer & Hematology Centers Baylor College of Medicine
Houston
Texas
77030
United States
University of Utah
Salt Lake City
Utah
84113
United States
Seattle Children's Hospital
Seattle
Washington
98105
United States
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
FG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
Number of Treatment-emergent Adverse Events (TEAEs)
TEAEs are AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occur during the post-treatment period but prior to initiation of other anticancer therapy. Number of TEAEs reported.
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Events
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs
NCI CTCAE version 4.0 was utilized for AE grading of severity: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). Number of NCI grade 3/4/5 Treatment-Emergent Adverse Events (AEs) reported
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Events
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
Primary
Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs)
Number of sponsor-identified irAEs (all grades) reported.
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Events
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
OG003
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Primary
Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs
Number of severe treatment-emergent sponsor-identified irAEs reported.
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Events
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
OG003
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Primary
Number of Treatment-emergent AEs of Special Interest (AESI)
AEs of special interest (AESI) are AEs required to be monitored, documented, and managed in a pre-specified manner as described in the protocol. Number of treatment-emergent AESI reported.
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Events
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
OG003
Primary
Number of NCI Grade 3/4/5 Treatment-emergent AESI
Number of NCI grade 3/4/5 treatment-emergent AESI reported
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Events
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
OG003
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Primary
Number of Participants With Any TEAE Resulting in Death
Number of participants with any TEAE resulting in death reported
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Participants
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
OG003
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Primary
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
Number of participants with new or worsened laboratory abnormalities (NCI-CTCAE All Grades) reported in Hematology, Electrolytes, Liver, Chemistry; Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE).
Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Posted
Number
Participants
Up to 36 months
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
Primary
Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1)
Number of participants who developed dose limiting toxicities (DLTs) in phase 1 reported
Only Phase 1 participants that were eligible for Dose Limiting Toxicity evaluation.
Posted
Number
Participants
Baseline to 28 days
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
OG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR <12 yr REGN2810 3mg/kg (Q2W)
Number of Participants Who Developed DLTs (Efficacy Phase)
Only Efficacy Phase participants that were eligible for Dose Limiting Toxicity evaluation.
Posted
Number
Participants
Up to 4 weeks post radiation therapy
ID
Title
Description
OG000
Cohort E Efficacy Phase ndDIPG (DLT AS)
Participants (3 to <12 years) with ndDIPG; DLT analysis set
OG001
Cohort F Efficacy Phase ndDIPG (DLT AS)
Participants (12 to 25 years) with ndDIPG; DLT analysis set
OG002
Cohort H Efficacy Phase ndHGG (DLT AS)
Participants (12 to 25 years) with ndHGG; DLT analysis set
OG003
Cohort I Efficacy Phase rHGG (DLT AS)
Participants (3 to <12 years) with rHGG; DLT analysis set
OG004
Cohort J Efficacy Phase rHGG (DLT AS)
Participants (12 to 25 years) with rHGG; DLT analysis set
Primary
Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum
Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type. Radiation type was collected, but not used for assessment; Due to sparse sampling, elimination half-life could not be calculated.
Posted
Median
Full Range
milligrams/Liter (mg/L)
Up to 24 months
ID
Title
Description
OG000
Cohort A Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; Pharmacokinetic Analysis Set (PKAS)
OG001
Cohort B Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (12 to <18 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; PKAS
OG002
Cohort C Phase 1 CNS 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory CNS tumors received REGN2810 3mg/kg Q2W; PKAS
OG003
Cohort C Phase 1 CNS 4.5mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory CNS tumors received REGN2810 4.5mg/kg Q2W; PKAS
Primary
Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum
Ctrough (trough concentration) of functional cemiplimab in serum reported.
Pharmacokinetic Analysis Set (PKAS): All treated participants who received any amount of study drug (SAF) and had at least 1 non-missing functional cemiplimab measurement following the first dose of cemiplimab (based on actual treatment received [as treated]); Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type.
Posted
Median
Full Range
mg/L
Up to Week 16
ID
Title
Description
OG000
Cohort A Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; Pharmacokinetic Analysis Set (PKAS)
OG001
Cohort B Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (12 to <18 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; PKAS
OG002
Cohort C Phase 1 CNS 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory CNS tumors received REGN2810 3mg/kg Q2W; PKAS
OG003
Cohort D Phase 1 CNS 3mg/kg Q2W (PKAS)
Primary
Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum
Cmax (peak concentration) of functional cemiplimab in serum reported.
Pharmacokinetic Analysis Set (PKAS): All treated participants who received any amount of study drug (SAF) and had at least 1 non-missing functional cemiplimab measurement following the first dose of cemiplimab (based on actual treatment received [as treated]); Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type.
Posted
Median
Full Range
mg/L
Up to Week 16
ID
Title
Description
OG000
Cohort A Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; Pharmacokinetic Analysis Set (PKAS)
OG001
Cohort B Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (12 to <18 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; PKAS
OG002
Cohort C Phase 1 CNS 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory CNS tumors received REGN2810 3mg/kg Q2W; PKAS
OG003
Cohort D Phase 1 CNS 3mg/kg Q2W (PKAS)
Primary
Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum
Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type; Due to sparse sampling, area under the curve could not be calculated.
Posted
Median
Full Range
mg*hr/L
Up to 24 months
ID
Title
Description
OG000
Cohort A Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; Pharmacokinetic Analysis Set (PKAS)
OG001
Cohort B Phase 1 ST 3mg/kg Q2W (PKAS)
Participants (12 to <18 years) with recurrent or refractory ST received REGN2810 3mg/kg Q2W; PKAS
OG002
Cohort C Phase 1 CNS 3mg/kg Q2W (PKAS)
Participants (0 to <12 years) with recurrent or refractory CNS tumors received REGN2810 3mg/kg Q2W; PKAS
OG003
Cohort D Phase 1 CNS 3mg/kg Q2W (PKAS)
Participants (12 to <18 years) with recurrent or refractory CNS received REGN2810 3mg/kg Q2W; PKAS
Primary
Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG)
PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined per Response Assessment in Neuro-Oncology (RANO)/Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria, or death due to any cause.
Only participants with newly diagnosed HGG (ndHGG) were assessed for this endpoint.
Posted
Number
95% Confidence Interval
Percentage of Participants
At 12 months
ID
Title
Description
OG000
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG >=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
Units
Counts
Participants
OG000
Primary
Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG)
OS was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last date that participant was documented to be alive. 95% CI is based on Kaplan-Meier method.
Only participants with ndDIPG and recurrent HGG (rHGG) were assessed for this endpoint.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 12 months
ID
Title
Description
OG000
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG <12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
OG001
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG >=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR)
ORR was defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR), as determined per standard criteria between the date of first study treatment and the date of the first objectively documented progression or the date of receiving another anti-cancer systemic therapy, whichever came first. Clopper-Person exact confidence interval
Posted
Number
95% Confidence Interval
Percentage of Participants
Approximately 24 months
ID
Title
Description
OG000
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
OG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
Number of Participants With Anti-REGN2810 Antibodies (ADA)
ADA status classified as: Positive; Pre-existing (baseline [BL] sample positive & all post BL ADA titers reported as < 9-fold BL titer value); Negative (all samples negative); ADA positive: Treatment-boosted (positive result at BL with ≥1 post BL titer result ≥9-fold BL titer value); Treatment-emergent (TE) (negative result or missing result at BL with ≥1 positive post BL result); TE: Persistent (positive result detected in ≥2 consecutive post BL samples separated by ≥ a 12/16-week post BL period with no ADA-negative results in-between, regardless of any missing samples; Indeterminate (positive result in last collection, regardless of any missing samples); Transient (not persistent or indeterminate, regardless of any missing samples)
ADA analysis set (AAS): all treated participants who received any amount of cemiplimab (SAF) & had ≥1 non-missing ADA result following first dose of cemiplimab (based on actual treatment received [as treated]).
By design, the study arms were expected to be reflective of tumor type/diagnosis
Posted
Count of Participants
Participants
1st follow-up visit, approximately 25 months
ID
Title
Description
OG000
Phase 1: 3mg/kg Q2W (AAS)
Participants received REGN2810 3 milligrams/kilogram (mg/kg) once every 2 weeks (Q2W); anti-drug antibody analysis set (AAS)
OG001
Phase 1: 4.5mg/kg Q2W (AAS)
Participants received REGN2810 4.5mg/kg Q2W; AAS
Time Frame
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Description
Not provided
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
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR < 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
2
3
0
3
3
3
EG001
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
4
5
0
5
5
5
EG002
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 CNS TUMOR <12 yr REGN2810 3mg/kg (Q2W)
2
3
0
3
2
3
EG003
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Phase 1 CNS TUMOR <12 yr REGN2810 4.5mg/kg (Q2W)
8
9
3
9
8
9
EG004
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 CNS TUMOR 12 to <18 yr REGN2810 3mg/kg (Q2W)
3
5
0
5
4
5
EG005
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG <12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
6
6
3
6
6
6
EG006
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG >=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
4
5
3
5
5
5
EG007
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG >=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
IIIrd nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Family stress
Social circumstances
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0034 events3 affected9 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected5 at risk
EG0074 events2 affected12 at risk
EG0081 events1 affected1 at risk
EG0091 events1 affected8 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Face oedema
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Accessory nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Auditory nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Autonomic nervous system imbalance
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Central nervous system necrosis
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysmetria
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Glossopharyngeal nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglossal nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
IIIrd nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Trigeminal nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
VIth nerve disorder
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Weight increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemoglobin increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Protein total decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngeal ulceration
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Respiration abnormal
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin candida
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal wound dehiscence
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Incision site erythema
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Procedural site reaction
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pseudomeningocele
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Optic atrophy
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid function disorder
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Papilloedema
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pupillary reflex impaired
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Personality change
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pseudoprogression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
External ear pain
Ear and labyrinth disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Family stress
Social circumstances
MedDRA (25.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
As all efficacy cohorts for this study have now been closed due to the futility criteria, Regeneron as Sponsor in collaboration with PNOC made a decision to close the study to further enrollment.
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.