Arginase Inhibitor INCB001158 as a Single Agent and in Co... | NCT02903914 | Trialant
NCT02903914
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Aug 5, 2025Actual
Enrollment
260Actual
Phase
Phase 1
Conditions
Metastatic Cancer
Solid Tumors
Colorectal Cancer (CRC)
Gastric Cancer
Head and Neck Cancer
Lung Cancer
Renal Cell Carcinoma (RCC)
Bladder Cancer
UC (Urothelial Cancer)
Mesothelioma
Interventions
INCB001158
Pembrolizumab
Countries
United States
Italy
Netherlands
Spain
Protocol Section
Identification Module
NCT ID
NCT02903914
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 01158-101
Secondary IDs
ID
Type
Description
Link
Mk3475 Keynote 741
Other Identifier
Merck
2017-002903-82
EudraCT Number
Brief Title
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
Official Title
Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (Formerly Known as CB1158) as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 14, 2016Actual
Primary Completion Date
Apr 30, 2020Actual
Completion Date
Aug 15, 2022Actual
First Submitted Date
Sep 9, 2016
First Submission Date that Met QC Criteria
Sep 13, 2016
First Posted Date
Sep 16, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 31, 2021
Results First Submitted that Met QC Criteria
Aug 31, 2021
Results First Posted Date
Sep 30, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 1, 2025
Last Update Posted Date
Aug 5, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
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
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
Detailed Description
This study is an open-label Phase 1 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
Single Agent INCB001158:
Patients with advanced/metastatic solid tumors will be enrolled into escalating monotherapy dose cohorts to determine the Recommended Phase 2 Dose (RP2D) of INCB001158. Additional patients with NSCLC, Colorectal Cancer (CRC), and other tumors including SCCHN, RCC, Gastric, Bladder and Melanoma will be enrolled at the single agent RP2D.
Combination Treatment:
Patients with advanced/metastatic NSCLC, Melanoma, Urothelial, Microsatellite Instability (MSI)/ Microsatellite Stable (MSS) CRC, Gastric, SCCHN and Mesothelioma will be enrolled into separate cohorts of combination therapy (INCB001158 and Pembrolizumab) to determine the RP2D.
In the dose expansion phase, additional patients with NSCLC, Melanoma, Urothelial, MSI/MSS CRC, Gastric, SCCHN and Mesothelioma will be treated with the combination of INCB001158 and Pembrolizumab at the RP2D.
All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.
Conditions Module
Conditions
Metastatic Cancer
Solid Tumors
Colorectal Cancer (CRC)
Gastric Cancer
Head and Neck Cancer
Lung Cancer
Renal Cell Carcinoma (RCC)
Bladder Cancer
UC (Urothelial Cancer)
Mesothelioma
Keywords
Immuno-Oncology
Checkpoint Inhibitors
Tumor Metabolism
Programmed cell death protein-1 (PD-1) inhibitor
Programmed death ligand 1 (PD-L1) inhibitor
Solid Tumors
RCC
MEL
NSCLC
Arginase
Arginase Inhibitor
INCB001158 (CB-1158)
SCCHN
GEJ
Immune Therapy
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
260Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
INCB00158 was administered as monotherapy at 50mg twice daily
Experimental
Monotherapy Part 1a: INCB001158 administered orally in patients with advanced/metastatic solid tumors. Escalating doses will be explored to determine the recommended phase 2 dose (RP2D).
Drug: INCB001158
INCB00158 was administered as monotherapy at 75mg twice daily
Experimental
Monotherapy Part 2a: INCB001158 administered orally at the RP2D in patients with advanced/metastatic NSCLC (EGFR and Anaplastic Lymphoma Kinase (ALK) negative) previously treated with Standard of Care (SOC).
Drug: INCB001158
INCB00158 was administered as monotherapy at 100mg twice daily
Experimental
Monotherapy Part 2b: INCB001158 administered orally at the RP2D in patients with advanced/metastatic CRC previously treated with SOC.
Drug: INCB001158
INCB00158 was administered as monotherapy at 150mg twice daily
Experimental
Monotherapy Part 2c: INCB001158 administered orally at the RP2D in patients with Bladder Cancer, Gastric or Gastroesophageal Junction (GEJ) Cancer, Renal Cell Cancer (RCC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Urothelial Cell Cancer (UCC), or Melanoma, previously treated with SOC.
Drug: INCB001158
INCB00158 was administered in combination with pembroluzimab at 50mg twice daily
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB001158
Drug
Arginase Inhibitor
INCB001158 50 mg BID in combination with pembrolizumab
INCB00158 was administered as monotherapy at 100mg twice daily
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.
up to study completion (up to approximately 3.5 years)
Secondary Outcomes
Measure
Description
Time Frame
Recommended Phase 2 Dose (RP2D) of INCB001158
The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.
12 weeks
RP2D of INCB001158 in Combination With Pembrolizumab
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
*Additional cohort specific criteria may apply
Inclusion Criteria:
Must be age 18 or older
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Life Expectancy of at least 3 months
Adequate hepatic, renal (moderately impaired renal function in cohort 1c only), cardiac, and hematologic function
Measurable disease by RECISTv1.1 criteria
Resolution of treatment-related toxicities
Willingness to avoid pregnancy or fathering children
Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3a - 3d
Exclusion Criteria:
Currently pregnant or lactating
Unable to receive oral medications
Unable to receive oral or IV hydration
Intolerance to prior anti-PD-1/PD-L1 therapy
Prior anti-PD-1 treatment for combination dose expansion cohorts 1c, 3e - 3h
Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)
Any other current or previous malignancy within 3 years except protocol allowed malignancies
Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: some cohort exceptions allow anti-PD-1 therapy)
Active known or suspected exclusionary autoimmune disease
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks
Concomitant therapy with valproic acid/valproate-containing therapies
Concomitant therapy with allopurinol and other xanthine oxidase inhibitors
History of known risks factors for bowel perforation
Symptomatic ascites or pleural effusion
Major surgery within 28 days before Cycle 1 Day 1
Active infection requiring within 2 weeks prior to first dose of study drug
Patients who have HIV, Hepatitis B or C
Conditions that could interfere with treatment or protocol-related procedures
Active, non-stable brain metastases or CNS disease
Known deficiencies or suspected defect in the urea cycle
Received live-virus vaccination within 30 days (seasonal flu vaccine allowed if non-live virus)
Naing A, Papadopoulos KP, Pishvaian MJ, Rahma O, Hanna GJ, Garralda E, Saavedra O, Gogov S, Kallender H, Cheng L, Smith M, Chen X, Kuriakose E, Bauer T. First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours. BMJ Oncol. 2024 May 9;3(1):e000249. doi: 10.1136/bmjonc-2023-000249. eCollection 2024.
260 enrolled participants: 107 in the Part 1a and Part 2 monotherapy groups; 147 in the Part 1b and Part 3 combination therapy groups; and 6 in Part 1c. Disposition data have been reported by dose level; efficacy data have been reported by tumor type, regardless of dose received. One Part 3 participant scheduled to receive INCB001158 100 mg actually received 75 mg; they were included in the Part 1b 75 mg arm for disposition analysis and in the Part 1c and Part 3 100 mg arm for efficacy analysis.
Recruitment Details
This global study (United States, Spain, and Italy) consisted of 3 parts: Part 1 was dose-escalation using a 3 + 3 design to determine the RP2D of INCB001158 as monotherapy (Part 1a) and in combination with pembrolizumab (Parts 1b and 1c); Part 2 and Part 3 consisted of tumor expansion cohorts to determine whether INCB001158 as monotherapy (Part 2) or in combination with pembrolizumab (Part 3) had sufficient antitumor activity and further evaluated the safety and tolerability of the RP2D.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
FG001
Part 1A: INCB001158 75 mg
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
Nov 10, 2020
Aug 31, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Factorial 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
Experimental
Monotherapy Part 2d: INCB001158 administered orally at the RP2D in patients with any tumor types in Parts 2a, 2b, or 2c.
Drug: INCB001158
INCB00158 was administered in combination with pembroluzimab at 75mg twice daily
Experimental
Combination Part 1b: INCB001158 and Pembrolizumab administered in patients with advanced/metastatic NSCLC, Melanoma, Urothelial Cell Cancer, MSI CRC, MSS CRC, Gastric or Gastroesophageal Junction (GEJ) Cancer, SCCHN and Mesothelioma. Multiple dose levels will be explored to determine the recommended phase 2 dose (RP2D).
Drug: INCB001158
Drug: Pembrolizumab
INCB00158 was administered in combination with pembroluzimab at 100mg twice daily
Experimental
Part 3a: INCB001158 and Pembrolizumab the combination RP2D in patients with advanced/metastatic NSCLC (EGFR and ALK negative) with disease progression on anti-PD-1 therapy or prolonged stable disease on Pembrolizumab in the immediate prior line of therapy.
Drug: INCB001158
Drug: Pembrolizumab
INCB001158 50 mg BID in combination with pembrolizumab
Experimental
Part C: evaluated a reduced dose of INCB001158 50 mg BID in combination with pembrolizumab with patients with moderately impaired renal function.
Drug: INCB001158
Drug: Pembrolizumab
INCB00158 was administered as monotherapy at 150mg twice daily
INCB00158 was administered as monotherapy at 50mg twice daily
INCB00158 was administered as monotherapy at 75mg twice daily
INCB00158 was administered in combination with pembroluzimab at 100mg twice daily
INCB00158 was administered in combination with pembroluzimab at 50mg twice daily
INCB00158 was administered in combination with pembroluzimab at 75mg twice daily
CB-1158
Pembrolizumab
Drug
PD-1 Inhibitor
INCB001158 50 mg BID in combination with pembrolizumab
INCB00158 was administered in combination with pembroluzimab at 100mg twice daily
INCB00158 was administered in combination with pembroluzimab at 75mg twice daily
Keytruda
INCB001158 was dosed orally BID.
12 weeks
Objective Response Rate (ORR)
ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.
Until disease progression/study discontinuation (up to approximately 5 years)
Percentage of Participants With the Indicated Best Overall Response (BOR)
BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.
Until disease progression/study discontinuation (up to approximately 5 years)
Duration of Response (DOR)
DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.
Until disease progression/study discontinuation (up to approximately 5 years)
Progression-free Survival (PFS)
PFS was defined as the length of time between the date of the first dose and the earlier of death or progressive disease as assessed by RECIST v1.1. Pleural mesothelioma was evaluated using modified RECIST criteria. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. In renally impaired participants, the 50 mg dose has comparable exposure to 100 mg in participants with normal renal function. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.
Until disease progression/study discontinuation (up to approximately 5 years)
Cmax of INCB001158 Following Single Escalating Doses for Part 1A
Cmax was defined as the maximum observed concentration of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Tmax of INCB001158 Following Single Escalating Doses for Part 1A
tmax was defined as the time of the maximum observed concentration of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
AUC0-t of INCB001158 Following Single Escalating Doses for Part 1A
AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
AUC0-inf of INCB001158 Following Single Escalating Doses for Part 1A
AUC0-inf was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 extrapolated to infinity.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
t1/2 of INCB001158 Following Single Escalating Doses for Part 1A
t1/2 was defined as the half-life of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
CL/F of INCB001158 Following Single Escalating Doses for Part 1A
CL/F was defined as the apparent oral dose clearance of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Vz/F of INCB001158 Following Single Escalating Doses for Part 1A
Vz/F was defined as the apparent volume of distribution of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Cmax of INCB001158 Following Multiple Escalating Doses for Part 1A
Cmax was defined as the maximum observed concentration of INCB001158.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Tmax of INCB001158 Following Multiple Escalating Doses for Part 1A
tmax was defined as the time of the maximum observed concentration of INCB001158.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
AUC0-t of INCB001158 Following Multiple Escalating Doses for Part 1A
AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
AUC0-tau of INCB001158 Following Multiple Escalating Doses for Part 1A
AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
t1/2 of INCB001158 Following Multiple Escalating Doses for Part 1A
t1/2 was defined as the half-life of INCB001158.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
CL/F of INCB001158 Following Multiple Escalating Doses for Part 1A
CL/F was defined as the apparent oral dose clearance of INCB001158.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Vz/F of INCB001158 Following Multiple Escalating Doses for Part 1A
Vz/F was defined as the apparent volume of distribution of INCB001158.
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Cmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
Cmax was defined as the maximum observed concentration of INCB001158.
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
Tmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
tmax was defined as the time of the maximum observed concentration of INCB001158.
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
AUC of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
AUC was defined as the area under the concentration-time curve of INCB001158.
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
Cmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
Cmax was defined as the maximum observed concentration of INCB001158.
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
Tmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
tmax was defined as the time of the maximum observed concentration of INCB001158.
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
AUC0-t of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
AUC0-tau of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
Cmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
Cmax was defined as the Maximum observed concentration of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.
Tmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
tmax was defined as the time of the maximum observed concentration of INCB001158.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.
AUC0-8h of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
AUC0-8h was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to 8 hours post-dose.
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
Scottsdale
Arizona
85258
United States
University of Arizona
Tucson
Arizona
85719
United States
Georgetown
Washington D.C.
District of Columbia
20007
United States
Johns Hopkins
Baltimore
Maryland
21287
United States
BIDMC
Boston
Massachusetts
02215
United States
DFCI
Boston
Massachusetts
02215
United States
Henry Ford
Detroit
Michigan
48202
United States
Sarah Cannon Research Institute at Tennessee Oncology
Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
FG002
Part 1A and Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
FG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
FG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
FG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
FG006
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
FG007
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
FG0008 subjects
FG0017 subjects
FG00285 subjects
FG0037 subjects
FG00410 subjects
FG00514 subjects
FG006123 subjects
FG0076 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0008 subjects
FG0017 subjects
FG00285 subjects
FG0037 subjects
FG00410 subjects
FG00514 subjects
FG006123 subjects
FG0076 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG00228 subjects
FG0030 subjects
FG004
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0029 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Symptomatic Deterioration
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
New Cancer Therapy
FG0002 subjects
FG0012 subjects
FG00221 subjects
FG0034 subjects
FG004
Didn't Return to Site
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Entered/Referred to Hospice Care
FG0001 subjects
FG0011 subjects
FG0028 subjects
FG0030 subjects
FG004
Follow-up Did Not Occur
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Systemic Treatment Options Necessary
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Consented to/Considered Other Clinical Study
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Clinical Disease Progression
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Completed Follow-up Period
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0032 subjects
FG004
Taken off Treatment per Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Refused Further Treatment/Contact
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Discontinued per Sponsor/Participant Agreement
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
BG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
BG002
Part 1A and Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
BG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
BG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
BG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
BG006
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
BG007
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0017
BG00285
BG0037
BG00410
BG00514
BG006123
BG0076
BG008260
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00056.5± 3.96
BG00161.7± 6.10
BG00261.4± 10.42
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0016
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
White or Causasian
Title
Measurements
BG0005
BG0017
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0002
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.
Safety Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab. Data collected through study completion have been reported.
Posted
Count of Participants
Participants
No
up to study completion (up to approximately 3.5 years)
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
OG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG006
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG007
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
Units
Counts
Participants
OG0008
OG0017
OG00285
OG003
Title
Denominators
Categories
Title
Measurements
OG0007
OG0017
OG00281
OG003
Secondary
Recommended Phase 2 Dose (RP2D) of INCB001158
The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.
Safety Population
Posted
Number
milligrams
12 weeks
ID
Title
Description
OG000
INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID
Monotherapy Part 1a: INCB001158 was administered orally in participants with advanced/metastatic solid tumors. Sequential dose escalation of single-agent INCB001158 took place in participants with advanced/metastatic solid tumors.
Units
Counts
Participants
OG000
Secondary
RP2D of INCB001158 in Combination With Pembrolizumab
INCB001158 was dosed orally BID.
Safety Population
Posted
Number
milligrams
12 weeks
ID
Title
Description
OG000
INCB001158 as Combination Therapy at 50, 75, and 100 mg BID
INCB001158 administered orally in patients at 50, 75, and 100 mg doses BID with advanced/metastatic solid tumors in combination with pembrolizumab (200 mg IV Q3W)
Units
Counts
Participants
OG00033
Secondary
Objective Response Rate (ORR)
ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.
Response Efficacy Evaluable Population (REEP): received ≥1 dose of INCB001158 or pembrolizumab, completed a Baseline scan, and met ≥1 protocol-defined criteria. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.
Posted
Number
95% Confidence Interval
percentage of participants
Until disease progression/study discontinuation (up to approximately 5 years)
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
Secondary
Percentage of Participants With the Indicated Best Overall Response (BOR)
BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.
REEP. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.
Posted
Number
percentage of participants
Until disease progression/study discontinuation (up to approximately 5 years)
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Secondary
Duration of Response (DOR)
DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.
REEP. Only participants with CR or PR were analyzed, and only cohorts with ≥5 objective responders were analyzed. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab (half the RP2D of INCB001158). It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.
Posted
Median
95% Confidence Interval
months
Until disease progression/study discontinuation (up to approximately 5 years)
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
Secondary
Progression-free Survival (PFS)
PFS was defined as the length of time between the date of the first dose and the earlier of death or progressive disease as assessed by RECIST v1.1. Pleural mesothelioma was evaluated using modified RECIST criteria. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. In renally impaired participants, the 50 mg dose has comparable exposure to 100 mg in participants with normal renal function. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.
PFS Efficacy Evaluable Population (Full Analysis Set): all participants who received at least 1 dose of INCB001158 or pembrolizumab. One participant was to be treated with INCB001158 100 mg + pembrolizumab but actually received INCB001158 75 mg + pembrolizumab. For PFS analysis, this participant was analyzed in their planned treatment group (INCB001158 100 mg + pembrolizumab) rather than in the actual treatment group.
Posted
Median
95% Confidence Interval
months
Until disease progression/study discontinuation (up to approximately 5 years)
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
Secondary
Cmax of INCB001158 Following Single Escalating Doses for Part 1A
Cmax was defined as the maximum observed concentration of INCB001158.
Pharmacokinetic (PK) Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab and contributed at least 1 PK sample
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
Secondary
Tmax of INCB001158 Following Single Escalating Doses for Part 1A
tmax was defined as the time of the maximum observed concentration of INCB001158.
PK Population
Posted
Median
Full Range
hours
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
AUC0-t of INCB001158 Following Single Escalating Doses for Part 1A
AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
AUC0-inf of INCB001158 Following Single Escalating Doses for Part 1A
AUC0-inf was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 extrapolated to infinity.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
t1/2 of INCB001158 Following Single Escalating Doses for Part 1A
t1/2 was defined as the half-life of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
CL/F of INCB001158 Following Single Escalating Doses for Part 1A
CL/F was defined as the apparent oral dose clearance of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
Vz/F of INCB001158 Following Single Escalating Doses for Part 1A
Vz/F was defined as the apparent volume of distribution of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
Cmax of INCB001158 Following Multiple Escalating Doses for Part 1A
Cmax was defined as the maximum observed concentration of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
Tmax of INCB001158 Following Multiple Escalating Doses for Part 1A
tmax was defined as the time of the maximum observed concentration of INCB001158.
PK Population
Posted
Median
Full Range
hours
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
AUC0-t of INCB001158 Following Multiple Escalating Doses for Part 1A
AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
AUC0-tau of INCB001158 Following Multiple Escalating Doses for Part 1A
AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.
PK Population. Only participants with available data were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
t1/2 of INCB001158 Following Multiple Escalating Doses for Part 1A
t1/2 was defined as the half-life of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
CL/F of INCB001158 Following Multiple Escalating Doses for Part 1A
CL/F was defined as the apparent oral dose clearance of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
Vz/F of INCB001158 Following Multiple Escalating Doses for Part 1A
Vz/F was defined as the apparent volume of distribution of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Secondary
Cmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
Cmax was defined as the maximum observed concentration of INCB001158.
PK Population. Only participants with available date were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
Secondary
Tmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
tmax was defined as the time of the maximum observed concentration of INCB001158.
PK Population. Only participants with available data were analyzed.
Posted
Median
Full Range
hours
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
Secondary
AUC of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
AUC was defined as the area under the concentration-time curve of INCB001158.
PK Population. Only participants with available date were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
Secondary
Cmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
Cmax was defined as the maximum observed concentration of INCB001158.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
ID
Title
Description
OG000
Part 2D: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors. Participants enrolled in Part 2D received INCB001158 tablets from C1D1 to C1D15, and then switched to INCB001158 capsules starting on C1D16 onwards.
Units
Counts
Participants
OG000
Secondary
Tmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
tmax was defined as the time of the maximum observed concentration of INCB001158.
PK Population
Posted
Median
Full Range
hours
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
ID
Title
Description
OG000
Part 2D: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors. Participants enrolled in Part 2D received INCB001158 tablets from C1D1 to C1D15, and then switched to INCB001158 capsules starting on C1D16 onwards.
Units
Counts
Participants
OG000
Secondary
AUC0-t of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
ID
Title
Description
OG000
Part 2D: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors. Participants enrolled in Part 2D received INCB001158 tablets from C1D1 to C1D15, and then switched to INCB001158 capsules starting on C1D16 onwards.
Units
Counts
Participants
OG000
Secondary
AUC0-tau of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.
PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
ID
Title
Description
OG000
Part 2D: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors. Participants enrolled in Part 2D received INCB001158 tablets from C1D1 to C1D15, and then switched to INCB001158 capsules starting on C1D16 onwards.
Units
Counts
Participants
OG000
Secondary
Cmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
Cmax was defined as the Maximum observed concentration of INCB001158.
PK Population. Analysis was conducted to compare INCB001158 50 mg + pembrolizumab in participants with renal impairment with INCB001158 50 mg or 75 mg in participants with normal renal function. It was pre-specified to collect data for only the Part 1A INCB001158 50 mg, Part 1A: INCB001158 75 mg, and Part 1C: INCB001158 50 mg + Pembrolizumab arms. Participants in the INCB001158 100 mg and 150 mg arms did not contribute to the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
Secondary
Tmax of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
tmax was defined as the time of the maximum observed concentration of INCB001158.
PK Population. Analysis was conducted to compare INCB001158 50 mg + pembrolizumab in participants with renal impairment with INCB001158 50 mg or 75 mg in participants with normal renal function. It was pre-specified to collect data for only the Part 1A INCB001158 50 mg, Part 1A: INCB001158 75 mg, and Part 1C: INCB001158 50 mg + Pembrolizumab arms. Participants in the INCB001158 100 mg and 150 mg arms did not contribute to the analysis.
Posted
Median
Full Range
hours
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 (Part 1A only) hours post-dose.
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
Secondary
AUC0-8h of INCB001158 in Participants With Renal Impairment (Part 1C) and Normal Renal Function (Part 1A)
AUC0-8h was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to 8 hours post-dose.
PK Population. Only participants with available data were analyzed. Analysis was conducted to compare INCB001158 50 mg + pembrolizumab in participants with renal impairment with INCB001158 50 mg or 75 mg in participants with normal renal function. It was pre-specified to collect data for only the Part 1A INCB001158 50 mg, Part 1A: INCB001158 75 mg, and Part 1C: INCB001158 50 mg + Pembrolizumab arms. Participants in the INCB001158 100 mg and 150 mg arms did not contribute to the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours x ng/mL
Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
ID
Title
Description
OG000
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
Time Frame
up to approximately 3.5 years
Description
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + pembrolizumab.
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
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
0
8
3
8
7
8
EG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
0
7
2
7
7
7
EG002
Part 1A and Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors
12
85
31
85
77
85
EG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
0
7
0
7
7
7
EG004
Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W). Participants in Part 1C had moderately impaired renal function.
3
16
6
16
16
16
EG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
3
14
5
14
13
14
EG006
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
24
123
47
123
116
123
EG007
Total
Total
42
260
94
260
243
260
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected16 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected123 at risk
EG0071 events1 affected260 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0025 events5 affected85 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Adrenal haemorrhage
Endocrine disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected85 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Empyema
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Fatigue
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Flushing
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Headache
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events2 affected85 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Malaise
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0025 events5 affected85 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Postoperative wound infection
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pyrexia
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Respirovirus test positive
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Seizure
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected85 at risk
EG003
Septic shock
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Soft tissue necrosis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Transaminases increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Vaginal fistula
Reproductive system and breast disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected16 at risk
EG0051 events1 affected14 at risk
EG0063 events3 affected123 at risk
EG0074 events4 affected260 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG00211 events11 affected85 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0024 events4 affected85 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0004 events3 affected8 at risk
EG0014 events3 affected7 at risk
EG00211 events10 affected85 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG00212 events11 affected85 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0029 events7 affected85 at risk
EG003
Asthenia
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0028 events8 affected85 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0025 events5 affected85 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0029 events8 affected85 at risk
EG003
Blood iron decreased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Chest pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Chills
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Cognitive disorder
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected7 at risk
EG00222 events18 affected85 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0027 events7 affected85 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected7 at risk
EG00217 events17 affected85 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0024 events3 affected85 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0025 events5 affected85 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected7 at risk
EG0024 events3 affected85 at risk
EG003
Dry eye
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0026 events6 affected85 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected7 at risk
EG00212 events12 affected85 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Eye pain
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Face oedema
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Fatigue
General disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events3 affected7 at risk
EG00223 events22 affected85 at risk
EG003
Feeling abnormal
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Haematochezia
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Haemorrhoids
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Headache
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0026 events6 affected85 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hot flush
Vascular disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG00212 events7 affected85 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0024 events3 affected85 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected85 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0028 events6 affected85 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected7 at risk
EG0026 events6 affected85 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Local swelling
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Malaise
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Metamorphopsia
Eye disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0023 events2 affected85 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0025 events5 affected85 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0027 events6 affected85 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0024 events4 affected85 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0003 events2 affected8 at risk
EG0014 events3 affected7 at risk
EG00221 events18 affected85 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0027 events4 affected85 at risk
EG003
Nodule
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19
Systematic Assessment
EG0003 events2 affected8 at risk
EG0010 events0 affected7 at risk
EG00212 events12 affected85 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pain
General disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0026 events6 affected85 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Paraesthesia oral
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Peripheral swelling
General disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Procedural pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected85 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Pyrexia
General disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected7 at risk
EG0025 events4 affected85 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0025 events4 affected85 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Renal vein thrombosis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected85 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected85 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Stoma site pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Temperature intolerance
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected85 at risk
EG003
Tumour ulceration
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D001745
Urinary Bladder Diseases
D000236
Adenoma
D018301
Neoplasms, Mesothelial
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000628114
CB-1158
C582435
pembrolizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG00612 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
1 subjects
FG0053 subjects
FG00624 subjects
FG0072 subjects
2 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
3 subjects
FG0056 subjects
FG00656 subjects
FG0073 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
2 subjects
FG0050 subjects
FG0068 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG004
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0050 subjects
FG0069 subjects
FG0071 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG004
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
67.0
± 8.12
BG00458.7± 11.64
BG00562.8± 10.81
BG00659.7± 11.94
BG00773.3± 7.69
BG00860.9± 10.9
39
BG0034
BG0046
BG0053
BG00643
BG0073
BG008109
Male
BG0003
BG0011
BG00246
BG0033
BG0044
BG00511
BG00680
BG0073
BG008151
70
BG0036
BG0049
BG00513
BG006109
BG0075
BG008224
Black or African American
Title
Measurements
BG0002
BG0010
BG00211
BG0031
BG0040
BG0050
BG0063
BG0071
BG00818
Asian
Title
Measurements
BG0001
BG0010
BG0023
BG0030
BG0041
BG0051
BG0064
BG0070
BG00810
American Indican/Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Native Hawaiian or Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Captured as "Other" in Database
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0066
BG0070
BG0087
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0081
10
BG0031
BG0040
BG0050
BG0067
BG0070
BG00821
Not Hispanic or Latino
Title
Measurements
BG0006
BG0016
BG00275
BG0036
BG00410
BG00514
BG006114
BG0076
BG008237
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0062
BG0070
BG0082
7
OG00410
OG00514
OG006123
OG0076
7
OG00410
OG00513
OG006123
OG0076
28
Title
Denominators
Categories
Title
Measurements
OG000100
Title
Denominators
Categories
Title
Measurements
OG000100
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
OG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG006
Part 1B: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG007
Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG008
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG0036
OG00410
OG00513
OG00610
OG00773
OG008118
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 41.0)
OG0020.0(0.0 to 45.9)
OG0030.0(0.0 to 45.9)
OG00410.0(0.3 to 44.5)
OG0057.7(0.2 to 36.0)
OG0060.0(0.0 to 30.8)
OG0071.4(0.0 to 7.4)
OG00811.0(6.0 to 18.1)
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
OG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG006
Part 1B: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG007
Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG008
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG0036
OG00410
OG00513
OG00610
OG00773
OG008118
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0081.7
Partial Response
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Stable Disease
Title
Measurements
OG00033.3
OG0010.0
OG00216.7
OG003
Progressive Disease
Title
Measurements
OG00066.7
OG00185.7
OG00283.3
OG003
Not Evaluable
Title
Measurements
OG0000.0
OG00114.3
OG0020.0
OG003
Not Assessed
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Missing
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
OG001
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
OG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG006
Part 1B: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG007
Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG008
Part 1c and Part 3, SCCHN: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W to participants with squamous cell carcinoma of the head and neck (SCCHN).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0071
OG0085
Title
Denominators
Categories
Title
Measurements
OG004NA(NA to NA)The KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
OG005NA(NA to NA)The KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
OG007NA(NA to NA)The KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
OG00812.4(4.2 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
OG002
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
OG005
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG006
Part 1B: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
OG007
Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG008
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
OG00410
OG00513
OG00611
OG00777
OG008119
Title
Denominators
Categories
Title
Measurements
OG0001.8(1.2 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0011.8(1.2 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0021.8(1.4 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0032.1(1.7 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0042.1(0.7 to 6.2)
OG0052.6(1.8 to 5.7)
OG0062.1(0.6 to 2.3)
OG0071.9(1.8 to 2.1)
OG0083.0(2.1 to 4.1)
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG000763± 0.30
OG0011310± 0.26
OG0021420± 0.30
OG0031990± 0.33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.0731
Other
OG002
OG003
pairwise geometric mean ratio (GMR)
0.933
2-Sided
90
0.784
1.110
Other
OG000
OG002
pairwise GMR
1.074
2-Sided
90
0.908
1.271
Other
OG001
OG002
pairwise GMR
1.230
2-Sided
90
1.034
1.463
Other
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG0003.9(2.0 to 4.1)
OG0012.0(2.0 to 6.2)
OG0024.0(2.1 to 6.1)
OG0036.0(3.8 to 6.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Kruskal-Wallis
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.1496
Other
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG0007700± 0.32
OG00113200± 0.34
OG00214200± 0.37
OG00321500± 0.35
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.2867
Other
OG002
OG003
pairwise GMR
1.007
2-Sided
90
0.825
1.230
Other
OG000
OG002
pairwise GMR
1.081
2-Sided
90
0.892
1.311
Other
OG001
OG002
pairwise GMR
1.234
2-Sided
90
1.011
1.507
Other
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG0008360± 0.35
OG00114100± 0.38
OG00216000± 0.42
OG00324400± 0.34
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.6167
Other
OG002
OG003
pairwise GMR
1.014
2-Sided
90
0.820
1.255
Other
OG000
OG002
pairwise GMR
1.043
2-Sided
90
0.849
1.281
Other
OG001
OG002
pairwise GMR
1.170
2-Sided
90
0.945
1.447
Other
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG0005.33± 0.25
OG0015.21± 0.17
OG0025.70± 0.13
OG0035.65± 0.15
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG0005980± 0.35
OG0015330± 0.38
OG0026240± 0.42
OG0036150± 0.34
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0037
Title
Denominators
Categories
Title
Measurements
OG00046000± 0.29
OG00140100± 0.22
OG00251300± 0.32
OG00350100± 0.30
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0036
Title
Denominators
Categories
Title
Measurements
OG000987± 0.28
OG0011880± 0.28
OG0021990± 0.26
OG0033370± 0.30
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.0745
Other
OG002
OG003
pairwise GMR
1.127
2-Sided
90
0.947
1.341
Other
OG000
OG002
pairwise GMR
0.991
2-Sided
90
0.833
1.180
Other
OG001
OG002
pairwise GMR
1.258
2-Sided
90
1.064
1.486
Other
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0036
Title
Denominators
Categories
Title
Measurements
OG0002.0(1.9 to 4.0)
OG0014.1(2.0 to 6.1)
OG0024.0(2.1 to 5.9)
OG0032.0(1.9 to 4.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Kruskal-Wallis
0.0518
Other
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0036
Title
Denominators
Categories
Title
Measurements
OG0007910± 0.26
OG00115000± 0.35
OG00216200± 0.38
OG00328100± 0.32
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.1723
Other
OG002
OG003
pairwise GMR
1.156
2-Sided
90
0.941
1.420
Other
OG000
OG002
pairwise GMR
0.976
2-Sided
90
0.794
1.198
Other
OG001
OG002
pairwise GMR
1.233
2-Sided
90
1.012
1.503
Other
Units
Counts
Participants
OG0006
OG0014
OG0024
OG0036
Title
Denominators
Categories
Title
Measurements
OG0008250± 0.27
OG00116600± 0.39
OG00218300± 0.34
OG00329700± 0.31
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.1705
Other
OG002
OG003
pairwise GMR
1.083
2-Sided
90
0.863
1.359
Other
OG000
OG002
pairwise GMR
0.902
2-Sided
90
0.719
1.132
Other
OG001
OG002
pairwise GMR
1.212
2-Sided
90
0.945
1.554
Other
Units
Counts
Participants
OG0006
OG0014
OG0024
OG0036
Title
Denominators
Categories
Title
Measurements
OG0005.54± 0.22
OG0015.22± 0.22
OG0025.70± 0.40
OG0036.83± 0.28
Units
Counts
Participants
OG0006
OG0014
OG0024
OG0036
Title
Denominators
Categories
Title
Measurements
OG0006060± 0.27
OG0014510± 0.39
OG0025470± 0.34
OG0035050± 0.31
Units
Counts
Participants
OG0006
OG0014
OG0024
OG0036
Title
Denominators
Categories
Title
Measurements
OG00048400± 0.34
OG00134000± 0.48
OG00245000± 0.09
OG00349700± 0.30
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0036
Title
Denominators
Categories
Fasted
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0036
Title
Measurements
OG000904± 0.19
OG0011840± 0.31
OG0021990± 0.26
OG003
Fed
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.7702
pairwise GMR
1.057
2-Sided
90
0.753
1.483
Other
OG001
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.9384
pairwise GMR
1.012
2-Sided
90
0.762
1.346
Other
OG002
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.6733
pairwise GMR
1.070
2-Sided
90
0.809
1.415
Other
OG003
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.3456
pairwise GMR
1.238
2-Sided
90
0.830
1.847
Other
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0036
Title
Denominators
Categories
Fasted
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0036
Title
Measurements
OG0002.0(2.0 to 4.0)
OG0014.0(2.0 to 4.3)
OG0024.0(2.1 to 5.9)
OG003
Fed
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Fed versus Fasted
Wilcoxon (Mann-Whitney)
0.0441
Other
OG001
Fed versus Fasted
Wilcoxon (Mann-Whitney)
0.4092
Other
OG002
Fed versus Fasted
Wilcoxon (Mann-Whitney)
0.7748
Other
OG003
Fed versus Fasted
Wilcoxon (Mann-Whitney)
0.1948
Other
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0036
Title
Denominators
Categories
Fasted
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0036
Title
Measurements
OG0006030± 0.26
OG00111900± 0.37
OG00213100± 0.31
OG003
Fed
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.7050
pairwise GMR
0.920
2-Sided
90
0.620
1.363
Other
OG001
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.7030
pairwise GMR
0.929
2-Sided
90
0.658
1.310
Other
OG002
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.9952
pairwise GMR
0.999
2-Sided
90
0.725
1.377
Other
OG003
Fed versus Fasted
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
0.4012
pairwise GMR
0.742
2-Sided
90
0.394
1.397
Other
5
Title
Denominators
Categories
Capsule
Title
Measurements
OG0002170± 0.23
Tablet
Title
Measurements
OG0002150± 0.29
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Tablet (test) versus Capsule (reference)
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)
0.9623
pairwise GMR
0.992
2-Sided
90
0.729
1.349
Other
5
Title
Denominators
Categories
Capsule
Title
Measurements
OG0003.8(1.8 to 6.0)
Tablet
Title
Measurements
OG0003.8(1.9 to 4.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Tablet (test) versus Capsule (reference)
Wilcoxon (Mann-Whitney)
0.7540
Other
5
Title
Denominators
Categories
Capsule
Title
Measurements
OG00020800± 0.22
Tablet
Title
Measurements
OG00019700± 0.27
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Tablet (test) versus Capsule (reference)
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
0.7514
pairwise GMR
0.951
2-Sided
90
0.718
1.261
Other
5
Title
Denominators
Categories
Capsule
Title
Measurements
OG00018000± 0.22
Tablet
Title
Measurements
OG00017200± 0.28
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Tablet (test) versus Capsule (reference)
ANOVA
1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)
0.7707
pairwise GMR
0.954
2-Sided
90
0.712
1.277
Other
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
Units
Counts
Participants
OG0008
OG0017
OG0020
OG0030
OG0046
Title
Denominators
Categories
Title
Measurements
OG000763± 0.30
OG0011310± 0.26
OG0041030± 0.21
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
Units
Counts
Participants
OG0008
OG0017
OG0020
OG0030
OG0046
Title
Denominators
Categories
Title
Measurements
OG0003.9(2.0 to 4.1)
OG0012.0(2.0 to 6.2)
OG0045.9(3.9 to 7.9)
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
OG003
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
OG004
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.