REVEAL Study of NKTR-262 in Combination With NKTR-214 and... | NCT03435640 | Trialant
NCT03435640
Sponsor
Nektar Therapeutics
Status
Terminated
Last Update Posted
Mar 8, 2023Actual
Enrollment
64Actual
Phase
Phase 1Phase 2
Conditions
Melanoma
Merkel Cell Carcinoma
Triple Negative Breast Cancer
Head and Neck Squamous Cell Carcinoma
Renal Cell Carcinoma
Colorectal Cancer
Sarcoma
Interventions
NKTR-262
bempegaldesleukin
nivolumab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03435640
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17-262-01
Secondary IDs
ID
Type
Description
Link
2018-004625-84
EudraCT Number
Brief Title
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
Official Title
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) With or Without Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies
Acronym
REVEAL
Organization
Nektar TherapeuticsINDUSTRY
Status Module
Record Verification Date
Feb 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Based on the overall results from the Phase 1 part of the study the sponsor decided to end the study. The decision was not due to safety reasons.
Expanded Access Info
No
Start Date
Mar 15, 2018Actual
Primary Completion Date
May 9, 2022Actual
Completion Date
May 9, 2022Actual
First Submitted Date
Feb 6, 2018
First Submission Date that Met QC Criteria
Feb 9, 2018
First Posted Date
Feb 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 30, 2022
Results First Submitted that Met QC Criteria
Feb 8, 2023
Results First Posted Date
Mar 8, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 8, 2023
Last Update Posted Date
Mar 8, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Nektar TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 results of the study, the decision was made not to start the Phase 2 part of the study and the study was terminated.
Detailed Description
Cancer treatments that couple pharmacological activation of tumor antigen presentation with activation and expansion of CD8+ T and natural killer (NK) cells in the tumor environment have the potential to induce an effective anti-tumor immune response in patients. NKTR-262 is a small molecule agonist of toll-like receptors (TLRs) 7/8 designed to be retained in the tumor micro-environment in order to activate antigen-presenting cells (APC), such as dendritic cells, to create new antigen-specific cytotoxic T cells. As a CD122-biased agonist, bempegaldesleukin monotherapy increases newly proliferative CD8+ T cells in tumors. NKTR-262 plus bempegaldesleukin is expected to increase expansion of antigen-specific CD8+ T cells. In preclinical studies, a single IT injection of NKTR-262 plus IV bempegaldesleukin resulted in complete abscopal effects in tumor models. Preliminary clinical data show bempegaldesleukin plus nivolumab enhances immune-stimulatory responses. The REVEAL trial will assess safety and anti-tumor activity of NKTR-262 with bempegaldesleukin +/- nivolumab for the treatment of selected cancers.
Melanoma (1st-line and relapsed/refractory)
Merkel Cell Carcinoma (2nd-line and relapsed/refractory)
Triple Negative Breast Cancer (1st- and 2nd-line and relapsed/refractory)
Renal Cell Carcinoma (1st-line and relapsed/refractory)
Colorectal Cancer (2nd-line and relapsed/refractory; MSI non-high)
Colorectal Cancer (2nd 3rd-line+, I-O therapy naive; relapsed/refractory; MSI high)
Head and Neck Squamous Cell Carcinoma (2nd-line and relapsed/refractory)
Sarcoma (2nd-line and relapsed/refractory)
Conditions Module
Conditions
Melanoma
Merkel Cell Carcinoma
Triple Negative Breast Cancer
Head and Neck Squamous Cell Carcinoma
Renal Cell Carcinoma
Colorectal Cancer
Sarcoma
Keywords
Bempegaldesleukin (NKTR-214)
NKTR-262
Nivolumab
Opdivo®
Metastatic
Locally advanced
Relapsed/Refractory
TLR7/8
CD122
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
64Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumab
Experimental
Phase 1: NKTR-262 in escalating doses, combined with bempegaldesleukin. The goal of this dose escalation part of the study is to establish a recommended Phase 1b dose for NKTR-262 + bempegaldesleukin with nivolumab, followed by a dose-confirmation cohort.
Drug: NKTR-262
Drug: bempegaldesleukin
Drug: nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NKTR-262
Drug
During Phase 1 Doublet: Patients receive escalating doses of NKTR-262 IT (starting dose 0.03 mg) in 3-week treatment cycles. During Phase 1 Doublet (Cohort A), Phase 2 Doublet: Patients were to receive the RP2D of NKTR-262.
During Phase 1 Triplet (Cohort B), and Phase 2 Triplet: Patients receive the RP2D of NKTR-262.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)
DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg).
There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.
The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher).
Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)
Objective Response Rate (ORR) per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D).
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by Blinded Independent Central Review (BICR).
From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma (HNSCC), or sarcoma.
Life expectancy > 12 weeks as determined by the Investigator.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Measurable disease per RECIST 1.1.
Patients enrolled in Cohorts 1-10, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease.
Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status.
Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies. Any liver lesion targeted for injection must not exceed 50 mm at the time of injection.
Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).
Key Exclusion Criteria:
Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s).
Patients treated with prior interleukin-2 (IL-2).
Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines.
Patients who have received systemic interferon (IFN)α within the previous 6 months prior to enrollment to the study.
Other active malignancy, except non-melanomic skin cancer
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
Unstable angina or myocardial infarction.
Congestive heart failure (NYHA Class III or IV).
Uncontrolled clinically significant arrhythmias.
Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic retinopathy, retinal hemorrhage, macular degeneration).
Uveal melanoma will be excluded
Patients with tumor that invade the superior vena cava or other major blood vessels.
Additional general and tumor specific inclusion and exclusion criteria will apply.
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3).
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 9, 2020
Nov 30, 2022
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
N/A
Intervention Model
Single Group 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
NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumab
bempegaldesleukin
Drug
During Phase 1 Doublet (Cohort A), and proposed Phase 2 Doublet: Patients receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles.
During Phase 1 Triplet (Cohort B), and proposed Phase 2 Triplet: Patients receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles.
NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumab
NKTR-214
nivolumab
Drug
During Phase 1 Triplet (Cohort B), and proposed Phase 2 Triplet: Patients receive a nivolumab flat dose of 360 mg administered in 3-week treatment cycles.
NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumab
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3).
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG002
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG003
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG004
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG005
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG006
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG007
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG008
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
FG009
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
FG010
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab IV (360 mg) q3w, starting in Cycle 1.
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG002
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG003
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG004
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG005
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG006
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG007
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG008
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
BG009
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 at the RP2D (3.84 mg) and bempegaldesleukin (0.006 mg/kg) q3w.
BG010
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 at the RP2D (3.84 mg) and bempegaldesleukin (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0024
BG0033
BG0044
BG0054
BG0064
BG0073
BG0088
BG00914
BG01014
BG01164
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00066.0(63 to 69)
BG00153.0(39 to 64)
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG002
ECOG Performance Status
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG Performance Status of 0 = Able to carry out all normal activities without restriction
ECOG Performance Status of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature
Count of Participants
Participants
Title
Denominators
Categories
ECOG 0
Title
Measurements
BG0002
BG001
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
Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)
DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg).
There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.
Posted
Count of Participants
Participants
The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher).
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3).The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG002
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG003
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG004
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG005
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG006
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG007
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG008
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
OG009
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
OG010
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)
Objective Response Rate (ORR) per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D).
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by Blinded Independent Central Review (BICR).
safety population
Posted
Number
95% Confidence Interval
percentage of participants
From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier.
ID
Title
Description
OG000
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
OG001
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered [Day 3] in Cycles 2-3).The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
2
3
1
3
3
3
EG002
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
3
4
1
4
4
4
EG003
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
1
3
1
3
3
3
EG004
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
4
4
1
4
4
4
EG005
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
4
4
1
4
4
4
EG006
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
1
4
1
4
4
4
EG007
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
2
3
3
3
3
3
EG008
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
5
8
3
8
8
8
EG009
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
9
14
2
14
14
14
EG010
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
5
14
5
14
14
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Syncope
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0091 affected14 at risk
EG0100 affected14 at risk
Cerebral infarction
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected3 at risk
EG0022 affected4 at risk
EG0031 affected3 at risk
EG0043 affected4 at risk
EG0052 affected4 at risk
EG0063 affected4 at risk
EG0071 affected3 at risk
EG0084 affected8 at risk
EG0098 affected14 at risk
EG0106 affected14 at risk
Influenza like illness
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0022 affected4 at risk
EG003
Chills
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Injection site pain
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Injection site erythema
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Face oedema
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Generalised oedema
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Injection site pruritus
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Localised oedema
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Application site irritation
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Application site nodule
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Device related thrombosis
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Injection site rash
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Injection site swelling
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Swelling
General disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected3 at risk
EG0022 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lip oedema
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Autoimmune arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0021 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Mediastinal mass
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Pulmonary venous thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
White blood cell count increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cortisol decreased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Occult blood positive
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Weight increased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Shock
Vascular disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Anaemia of chronic disease
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Post procedural discharge
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Procedural site reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Asthenopia
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blepharochalasis
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Corneal opacity
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Eye discharge
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Open angle glaucoma
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Photophobia
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Photopsia
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Retinal exudates
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Device occlusion
Product Issues
MedDRA 20.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 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
There are restrictions to the PI's rights to discuss or publish trial results.