A Study of ARRY-382 in Combination With Pembrolizumab for... | NCT02880371 | Trialant
NCT02880371
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Jun 16, 2022Actual
Enrollment
82Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumors
Interventions
ARRY-382
Pembrolizumab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02880371
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ARRAY-382-201
Secondary IDs
ID
Type
Description
Link
C4261001
Other Identifier
Alias Study Number
Brief Title
A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors
Official Title
A Phase 1b/2 Study of ARRY-382 in Combination With Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
May 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was halted prematurely due to insufficient efficacy. Not due to safety reasons.
Expanded Access Info
No
Start Date
Sep 1, 2016Actual
Primary Completion Date
Sep 17, 2019Actual
Completion Date
Oct 24, 2019Actual
First Submitted Date
Aug 2, 2016
First Submission Date that Met QC Criteria
Aug 23, 2016
First Posted Date
Aug 26, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 4, 2022
Results First Submitted that Met QC Criteria
May 21, 2022
Results First Posted Date
Jun 16, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 21, 2022
Last Update Posted Date
Jun 16, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
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 is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).
Detailed Description
ARRY-382 is an inhibitor of CSF1R (colony-stimulating factor-1 receptor).
Each phase of the study consists of a 28-day screening period; 21-day treatment cycles with the combination of ARRY-382 and pembrolizumab until disease progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, or death (or other discontinuation criteria are met), and a 30-day safety follow-up period. Patients in all cohorts/phases will be monitored for overall survival (OS) until 1 year after the date of the last patient's first visit.
Conditions Module
Conditions
Advanced Solid Tumors
Keywords
Advanced Solid Tumors
Pembrolizumab
ARRY-382
CSF-1R
CSF1R
cfms
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
82Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1b/Part A
Experimental
Patients in Part A will receive escalating doses of single-agent ARRY-382 in combination with 2 mg/kg pembrolizumab.
Drug: ARRY-382
Drug: Pembrolizumab
Phase 2
Experimental
Patients in Phase 2 will receive the MTD/RP2D dose of ARRY-382 determined during Part A in combination with 200mg pembrolizumab.
Drug: ARRY-382
Drug: Pembrolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ARRY-382
Drug
ARRAY-382 will be taken by mouth once daily at a fixed dose.
Phase 1b/Part A
Phase 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)
DLT: adverse event (AE) or abnormal laboratory value not clearly attributable to an extraneous cause, such as disease progression, intercurrent illness, or concomitant medications occurring during 21 days of Cycle 1, met 1 of the criteria A) nonhematologic AEs: recurring grade 2 pneumonitis, grade 3 events (irAE, QTcF prolongation, rash; other grade 3/4 except alopecia, nausea, diarrhea, vomiting, tumor flare, pseudoprogression, endocrinopathy); B) hematology AEs/laboratory abnormalities: grade 4 events except lymphopenia, neutropenia, electrolyte imbalances or abnormalities, grade 3 thrombocytopenia, febrile neutropenia, grade 4 AST/ALT elevation, grade 3 AST/ALT elevation lasting >7 days, associated with bilirubin levels>=2*ULN or international normalized ratio >1.5, grade 3 bilirubin elevation >=3, CK elevation >=grade 3 lasting, increase in creatinine >=1.5*baseline value, dose delay (dose interruption for >14 days) or other (inability to receive at least 67% of ARRY-382 doses).
Cycle 1 (up to 21 days)
Phase 2 Cohorts: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
From day of first dose to 30 days after last dose (maximum up to 13.5 months)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1b, Part A: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator review of radiographic disease assessments per RECIST v1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria
All Study Parts:
Diagnosis of cancer that has been histologically or cytologically confirmed
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Part A (1 of the following):
Ovarian cancer, triple-negative breast cancer, head and neck squamous cell cancer, bladder cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or gastric cancer that is measurable or evaluable, nonmeasurable as defined by RECIST v1.1 and meets 1 of the following criteria:
is refractory to standard of care
no standard therapy available
patient refuses standard therapy
Advanced, unresectable, or metastatic melanoma with or without prior treatment and measurable or evaluable, nonmeasurable disease as defined by RECIST v1.1
Advanced/metastatic PD-L1-positive NSCLC (defined as a tumor proportion score [TPS] ≥ 50%) with measurable or evaluable, non-measurable disease as defined by RECIST v1.1 (1 of the following):
1) No prior systemic chemotherapy if tumor does not have EGFR or ALK genomic aberrations
2) Disease progression on or after platinum-containing chemotherapy;
3) If tumor has EGFR or ALK genomic aberrations, disease progression on an FDA-approved therapy for EGFR or ALK genomic tumor aberrations
Phase 2 (1 of the following):
Advanced/metastatic solid tumor with PD as defined by RECIST 1.1 or irRC on an anti-PD-1- or anti-PD-L1-containing regimen as their most recent prior therapy
Advanced/metastatic epithelial ovarian cancer, peritoneal cancer or tubal cancer with measurable disease as defined by RECIST 1.1, that had progressed within 6 months of completing ≥ 4 cycles of platinum-based therapy
Advanced/metastatic PDA that is locally advanced, unresectable or metastatic with measurable disease as defined by RECIST v1.1 in patients who have received at least one prior line of systemic therapy for their disease
Key Exclusion Criteria
Prior treatment as follows:
Part A: an immune CPI (e.g., PD-1, PD-L1, or cytotoxic T-lymphocyte antigen 4 [CTLA-4] inhibitor).
NOTE: For patients with melanoma, prior treatment with ipilimumab is allowed if it was administered as adjuvant therapy and treatment was completed at least 3 months prior to enrollment.
Phase 2:
A CSF-1R inhibitor or CSF-1 (or MCSF) inhibitor.
prOVCA and PDA patients only: an immune CPI (e.g., PD-1, PD-L1, or CTLA-4 inhibitor)
Symptomatic brain metastasis at screening
Active autoimmune disease, documented history of autoimmune syndrome or disease, or a chronic medical condition that requires chronic steroid therapy or immunosuppressive medication
History of pneumonitis or interstitial lung disease
Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study
Johnson M, Dudek AZ, Sukari A, Call J, Kunk PR, Lewis K, Gainor JF, Sarantopoulos J, Lee P, Golden A, Harney A, Rothenberg SM, Zhang Y, Goldman JW. ARRY-382 in Combination with Pembrolizumab in Patients with Advanced Solid Tumors: Results from a Phase 1b/2 Study. Clin Cancer Res. 2022 Jun 13;28(12):2517-2526. doi: 10.1158/1078-0432.CCR-21-3009.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
There was an amendment in protocol, which removed originally designed Part B and C, due to low enrolment. Post-implementation of this amendment 2, Part B and C were replaced with 3 cohorts in Phase 2. Study then had Part A (Phase 1b), and 3 cohorts in Phase 2. Cohorts of Phase 2 were as follows: 1) PD-1/PD-L1 inhibitor-refractory cohort, 2) pancreatic ductal adenocarcinoma cohort and 3) platinum-resistant ovarian cancer cohort.
Recruitment Details
This study had 2 phases: Phase 1B and 2. Originally, Phase 1b of the study had Part A and B. Part A was dose escalation in participants with selected advanced solid tumors. Part B was expansion in melanoma participants. Part C was a part of Phase 2, in participants with non-small cell lung cancer (NSCLC).
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 milligrams (mg) orally, once daily (QD) in combination with pembrolizumab at a dose of 2 milligram per kilogram (mg/kg) intravenously (IV) every 3 weeks (Q3W) in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Periods
Title
Milestones
Reasons Not Completed
Phase 1b
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 24, 2018
Apr 4, 2022
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Pembrolizumab
Drug
Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
Phase 1b/Part A
Phase 2
From day of first dose to 30 days after last dose (maximum up to 34.7 months)
Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)
DOR was defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression, or death due to any cause after achieving a response. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures < 10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. DOR was estimated using the Kaplan-Meier method.
From date of first documented CR or PR up to disease progression or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)
PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v1.1, or death due to any cause, whichever occurs first. If a participant did not have a PFS event at the time of the analysis cut-off or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
From day of first dose until disease progression or death due to any cause or till last tumor assessment date (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)
OS was defined as the time from the start of treatment to the date of death due to any cause. If a death was not observed by the date of the analysis cut-off, OS was censored at the date of last contact. OS was estimated using the Kaplan-Meier method.
From day of first dose till death due to any cause or date of last contact (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR)
irRR was defined as the percentage of participants who achieved immune-related best overall response (irBOR) of immune-related CR (irCR) or immune-related PR (irPR), as determined by the investigator per immune related response criteria (irRC). irBOR was the best response using irRC recorded from the start of study treatment until the end of treatment. irCR was the disappearance of all target lesions, irPR was a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
From day of first dose till up to end of study treatment (for Phase 1b: maximum up to 33.7 months, for Phase 2: maximum up to 12.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)
irPFS was defined as the time from the start of treatment to the time of first documented progression per irRC, or death due to any cause. irRC criteria for progression for 1) Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%); 2) New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. For the analysis of irPFS, Kaplan-Meier method was used.
From the start of treatment to the time of first documented progression, or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation
Tumor markers were measured for tumor type from serum samples obtained from participants in Phase 2. Mean change from baseline was reported in this outcome measure.
Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment discontinuation (before 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03
Abnormalities: Albumin (hypoalbuminemia),Alkaline phosphatase (ALP increased), Alanine aminotransferase (ALT increased), Aspartate aminotransferase (AST increased),Total bilirubin (TBL increased), Creatinine (increased), Corrected calcium (hypocalcemia/hypercalcemia), Creatine kinase (CK increased), Glucose (hypoglycemia/hyperglycemia), Amylase (increased), Lipase (increased) ,Phosphate (hypophosphatemia), Magnesium (hypomagnesemia/hypermagnesemia), Potassium (hypokalemia/hyperkalemia), Sodium (hyponatremia/hypernatremia). Participants with all grades and grade 3/4 abnormalities were reported. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening.
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03
Hematology abnormalities: Hemoglobin (anemia/hemoglobin increased), Platelets (count decreased), Leukocytes (count decreased/increased), Neutrophils (count decreased), Lymphocytes (count increased/decreased). Coagulation abnormalities: International Normalized Ratio (INR increased), Partial thromboplastin time(PTT)/Activated partial thromboplastin Time (aPTT, time prolonged). Abnormalities were graded by CTCAE grade 4.03 as Grade 1= mild; Grade 2 = moderate; Grade 3/Grade 4 = severe/life-threatening. Participants with all grades and grade 3/4 abnormalities were reported.
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests
Liver function parameters/abnormalities: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): >3* upper limit of normal (ULN), >5*ULN, >8*ULN, >10*ULN, >20*ULN; Bilirubin >1.5*ULN, >2*ULN; Alkaline phosphatase (ALP) >2*ULN, >3*ULN.
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades
Thyroid panel laboratory parameters/abnormalities: thyrotropin, free triiodothyronine (T3), free thyroxine (T4). Shift in thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing is reported in this outcome measure.
Baseline, 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding
Urinalysis laboratory parameters/abnormalities: Decimal logarithm of reciprocal of hydrogen ion activity (pH), specific gravity, protein, glucose, ketones, nitrite, blood, leukocyte esterase, microscopy (if urine tested positive for blood or protein). Clinical significance was judged by investigator.
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature and weight. Low SBP: less than or equal to (<=)90 millimeter of mercury (mmHg) with decrease from baseline of >=20 mmHg. High SBP: >=160 mmHg with increase from baseline of >=20 mmHg. Low DBP: <=50 mmHg with decrease from baseline of >=15 mmHg. High DBP: >=100 mmHg with increase from baseline of >=15 mmHg. Low heart rate: <=50 beats/min with decrease from baseline of >=15 beats/min. High heart rate: >=120 beats/min with increase from baseline of >=15 beats/min. Low temperature: <=36 degree Celsius (C). High temperature: >=37.5 degree C. Low Weight: decrease from baseline >=20%. High weight: increase from baseline >=10%.
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382
The lower limit of quantitation (LLOQ) for analyte ARRY-382 was 5.00 nanogram per milliliter (ng/mL).
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hour(hr) (±5 min), 2 hours(hrs) (±10 min), 4 hrs (±20 min) and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469099 was reported in this outcome measure. The LLOQ for analyte AR00469099 was 1.00 ng/mL.
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469100 was reported in this outcome measure. The LLOQ for analyte AR00469100 was 1.00 ng/mL.
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00470870 was reported in this outcome measure. The LLOQ for analyte AR00470870 was 1.00 ng/mL.
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
AUCtau was defined as area under the plasma concentration-time curve over the dosing interval, where dosing interval was 24 hours.
0 to 24 hrs after administration of ARRY-382 on Day 1 of Cycle 2
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Cmax was obtained from plasma concentration time curve. Cmax at single dose was reported at Cycle1 Day 1 and Cmax at steady state was reported at Cycle 2 Day 1.
Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Measured concentration at the pre-dose at steady-state.
Pre dose of ARRY-382 (120 minutes prior to administration) on Day 1 of Cycle 2
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Tmax was obtained from plasma concentration time curve. Tmax at single dose was reported at Cycle 1 Day 1 and Tmax at steady state was reported at Cycle 2 Day 1.
Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Different MR reported for single dose calculated at Cycle 1 Day 1 were as follows: 1) MRAUClast = ratio of AUClast values of the metabolite compared to parent, corrected for molecular weight, where AUClast was area under the plasma concentration-time curve from zero to the last measurable time point; 2) MRCmax = ratio of Cmax values of the metabolite compared to parent, corrected for molecular weight. Different MR reported for steady state calculated at Cycle 2 Day 1 were as follows: 1) MRAUCtau,ss = ratio of AUCtau,ss values of the metabolite compared to parent, corrected for molecular weight, where AUCtau was area under the plasma concentration-time curve over a dosing interval at steady-state; 2) MRCmax,ss = Ratio of Cmax,ss values of the metabolite compared to parent, corrected for molecular weight.
Pre dose of ARRY-382 (120 minutes prior to administration),1 hrs (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Accumulation ratio was calculated and reported for Cmax as RCmax and for AUC as RAUC. RCmax = Cmax at steady-state on Day 1 of Cycle 2 divided by Cmax on Day 1 of Cycle 1. RAUC = AUC from zero to 8 hours after drug administration at steady-state on Day 1 of Cycle 2 divided by AUC from zero to 8 hours after drug administration on Day 1 of Cycle 1.
Pre dose of ARRY-382 (120 minutes prior to administration),1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
FG005
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a programmed cell death receptor 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) inhibitor-containing regimen as their most recent prior line of therapy and were new to prior colony-stimulating factor 1 receptor (CSF-1R) or colony-stimulating factor 1(CSF-1) inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior checkpoint inhibitor (CPI) therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
FG007
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
FG0006 subjects
FG0017 subjects
FG0027 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Treated
FG0006 subjects
FG0016 subjects
FG0027 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0006 subjects
FG0017 subjects
FG0026 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participants terminated by Sponsor
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0004 subjects
FG0016 subjects
FG0025 subjects
FG0031 subjects
FG004
Enrolled but not Treated
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants of Phase 1b were different from Phase 2.
FG0010 subjectsParticipants of Phase 1b were different from Phase 2.
FG0020 subjectsParticipants of Phase 1b were different from Phase 2.
FG0030 subjectsParticipants of Phase 1b were different from Phase 2.
FG0042 subjectsParticipants enrolled for Phase 2 were different from participants enrolled for Phase 1b.
FG00520 subjectsParticipants enrolled for Phase 2 were different from participants enrolled for Phase 1b.
FG00628 subjectsParticipants enrolled for Phase 2 were different from participants enrolled for Phase 1b.
FG00711 subjectsParticipants enrolled for Phase 2 were different from participants enrolled for Phase 1b.
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Enrolled but not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline characteristics were reported for full analysis set (FAS). FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
BG005
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
BG007
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0027
BG0031
BG0042
BG00519
BG00627
BG00711
BG00879
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
BG00063.7± 12.4
BG00152.2± 16.0
BG00254.7± 12.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)
DLT: adverse event (AE) or abnormal laboratory value not clearly attributable to an extraneous cause, such as disease progression, intercurrent illness, or concomitant medications occurring during 21 days of Cycle 1, met 1 of the criteria A) nonhematologic AEs: recurring grade 2 pneumonitis, grade 3 events (irAE, QTcF prolongation, rash; other grade 3/4 except alopecia, nausea, diarrhea, vomiting, tumor flare, pseudoprogression, endocrinopathy); B) hematology AEs/laboratory abnormalities: grade 4 events except lymphopenia, neutropenia, electrolyte imbalances or abnormalities, grade 3 thrombocytopenia, febrile neutropenia, grade 4 AST/ALT elevation, grade 3 AST/ALT elevation lasting >7 days, associated with bilirubin levels>=2*ULN or international normalized ratio >1.5, grade 3 bilirubin elevation >=3, CK elevation >=grade 3 lasting, increase in creatinine >=1.5*baseline value, dose delay (dose interruption for >14 days) or other (inability to receive at least 67% of ARRY-382 doses).
Dose-determining set (DDS) included all participants in Phase 1b who received at least 67% of the planned cumulative dose of ARRY-382 during Cycle 1 or discontinued the treatment because of DLT.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0022
Primary
Phase 2 Cohorts: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Number
95% Confidence Interval
percentage of participants
From day of first dose to 30 days after last dose (maximum up to 13.5 months)
ID
Title
Description
OG000
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator review of radiographic disease assessments per RECIST v1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Number
95% Confidence Interval
percentage of participants
From day of first dose to 30 days after last dose (maximum up to 34.7 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG001
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)
DOR was defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression, or death due to any cause after achieving a response. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures < 10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. DOR was estimated using the Kaplan-Meier method.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was evaluated in participants who achieved an objective response. "Overall Number of participants Analyzed" =0, signifies participants did not had documented CR or PR for respective reporting arms.
Posted
Median
95% Confidence Interval
months
From date of first documented CR or PR up to disease progression or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)
PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v1.1, or death due to any cause, whichever occurs first. If a participant did not have a PFS event at the time of the analysis cut-off or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Median
95% Confidence Interval
months
From day of first dose until disease progression or death due to any cause or till last tumor assessment date (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)
OS was defined as the time from the start of treatment to the date of death due to any cause. If a death was not observed by the date of the analysis cut-off, OS was censored at the date of last contact. OS was estimated using the Kaplan-Meier method.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Median
95% Confidence Interval
months
From day of first dose till death due to any cause or date of last contact (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR)
irRR was defined as the percentage of participants who achieved immune-related best overall response (irBOR) of immune-related CR (irCR) or immune-related PR (irPR), as determined by the investigator per immune related response criteria (irRC). irBOR was the best response using irRC recorded from the start of study treatment until the end of treatment. irCR was the disappearance of all target lesions, irPR was a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Number
95% Confidence Interval
percentage of participants
From day of first dose till up to end of study treatment (for Phase 1b: maximum up to 33.7 months, for Phase 2: maximum up to 12.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)
irPFS was defined as the time from the start of treatment to the time of first documented progression per irRC, or death due to any cause. irRC criteria for progression for 1) Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%); 2) New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. For the analysis of irPFS, Kaplan-Meier method was used.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Median
95% Confidence Interval
months
From the start of treatment to the time of first documented progression, or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation
Tumor markers were measured for tumor type from serum samples obtained from participants in Phase 2. Mean change from baseline was reported in this outcome measure.
FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was planned in prOVCA cohort. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
microgram per milliliter
Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment discontinuation (before 13.5 months)
ID
Title
Description
OG000
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Count of Participants
Participants
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03
Abnormalities: Albumin (hypoalbuminemia),Alkaline phosphatase (ALP increased), Alanine aminotransferase (ALT increased), Aspartate aminotransferase (AST increased),Total bilirubin (TBL increased), Creatinine (increased), Corrected calcium (hypocalcemia/hypercalcemia), Creatine kinase (CK increased), Glucose (hypoglycemia/hyperglycemia), Amylase (increased), Lipase (increased) ,Phosphate (hypophosphatemia), Magnesium (hypomagnesemia/hypermagnesemia), Potassium (hypokalemia/hyperkalemia), Sodium (hyponatremia/hypernatremia). Participants with all grades and grade 3/4 abnormalities were reported. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Count of Participants
Participants
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03
Hematology abnormalities: Hemoglobin (anemia/hemoglobin increased), Platelets (count decreased), Leukocytes (count decreased/increased), Neutrophils (count decreased), Lymphocytes (count increased/decreased). Coagulation abnormalities: International Normalized Ratio (INR increased), Partial thromboplastin time(PTT)/Activated partial thromboplastin Time (aPTT, time prolonged). Abnormalities were graded by CTCAE grade 4.03 as Grade 1= mild; Grade 2 = moderate; Grade 3/Grade 4 = severe/life-threatening. Participants with all grades and grade 3/4 abnormalities were reported.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Count of Participants
Participants
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests
Liver function parameters/abnormalities: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): >3* upper limit of normal (ULN), >5*ULN, >8*ULN, >10*ULN, >20*ULN; Bilirubin >1.5*ULN, >2*ULN; Alkaline phosphatase (ALP) >2*ULN, >3*ULN.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Count of Participants
Participants
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades
Thyroid panel laboratory parameters/abnormalities: thyrotropin, free triiodothyronine (T3), free thyroxine (T4). Shift in thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing is reported in this outcome measure.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Count of Participants
Participants
Baseline, 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding
Urinalysis laboratory parameters/abnormalities: Decimal logarithm of reciprocal of hydrogen ion activity (pH), specific gravity, protein, glucose, ketones, nitrite, blood, leukocyte esterase, microscopy (if urine tested positive for blood or protein). Clinical significance was judged by investigator.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Posted
Count of Participants
Participants
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature and weight. Low SBP: less than or equal to (<=)90 millimeter of mercury (mmHg) with decrease from baseline of >=20 mmHg. High SBP: >=160 mmHg with increase from baseline of >=20 mmHg. Low DBP: <=50 mmHg with decrease from baseline of >=15 mmHg. High DBP: >=100 mmHg with increase from baseline of >=15 mmHg. Low heart rate: <=50 beats/min with decrease from baseline of >=15 beats/min. High heart rate: >=120 beats/min with increase from baseline of >=15 beats/min. Low temperature: <=36 degree Celsius (C). High temperature: >=37.5 degree C. Low Weight: decrease from baseline >=20%. High weight: increase from baseline >=10%.
Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Count of Participants
Participants
First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382
The lower limit of quantitation (LLOQ) for analyte ARRY-382 was 5.00 nanogram per milliliter (ng/mL).
Pharmacokinetic (PK) set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382. Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hour(hr) (±5 min), 2 hours(hrs) (±10 min), 4 hrs (±20 min) and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469099 was reported in this outcome measure. The LLOQ for analyte AR00469099 was 1.00 ng/mL.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00469099. Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469100 was reported in this outcome measure. The LLOQ for analyte AR00469100 was 1.00 ng/mL.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00469100. Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870
Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00470870 was reported in this outcome measure. The LLOQ for analyte AR00470870 was 1.00 ng/mL.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00470870. Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter
Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
AUCtau was defined as area under the plasma concentration-time curve over the dosing interval, where dosing interval was 24 hours.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanogram per milliliter
0 to 24 hrs after administration of ARRY-382 on Day 1 of Cycle 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Cmax was obtained from plasma concentration time curve. Cmax at single dose was reported at Cycle1 Day 1 and Cmax at steady state was reported at Cycle 2 Day 1.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter
Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Measured concentration at the pre-dose at steady-state.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter
Pre dose of ARRY-382 (120 minutes prior to administration) on Day 1 of Cycle 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Tmax was obtained from plasma concentration time curve. Tmax at single dose was reported at Cycle 1 Day 1 and Tmax at steady state was reported at Cycle 2 Day 1.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Median
Full Range
hours
Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Different MR reported for single dose calculated at Cycle 1 Day 1 were as follows: 1) MRAUClast = ratio of AUClast values of the metabolite compared to parent, corrected for molecular weight, where AUClast was area under the plasma concentration-time curve from zero to the last measurable time point; 2) MRCmax = ratio of Cmax values of the metabolite compared to parent, corrected for molecular weight. Different MR reported for steady state calculated at Cycle 2 Day 1 were as follows: 1) MRAUCtau,ss = ratio of AUCtau,ss values of the metabolite compared to parent, corrected for molecular weight, where AUCtau was area under the plasma concentration-time curve over a dosing interval at steady-state; 2) MRCmax,ss = Ratio of Cmax,ss values of the metabolite compared to parent, corrected for molecular weight.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pre dose of ARRY-382 (120 minutes prior to administration),1 hrs (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Secondary
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Accumulation ratio was calculated and reported for Cmax as RCmax and for AUC as RAUC. RCmax = Cmax at steady-state on Day 1 of Cycle 2 divided by Cmax on Day 1 of Cycle 1. RAUC = AUC from zero to 8 hours after drug administration at steady-state on Day 1 of Cycle 2 divided by AUC from zero to 8 hours after drug administration on Day 1 of Cycle 1.
PK set included all participants who had received any active study intervention (ARRY-382), with at least one postdose blood draw to determineplasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pre dose of ARRY-382 (120 minutes prior to administration),1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Time Frame
Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Description
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
1
2
1
2
2
2
EG005
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
20
27
15
27
26
27
EG007
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
5
11
5
11
10
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG0030 affected1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Peritonitis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Rash morbilliform
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urine output decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cerebral thrombosis
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
confusional state
Psychiatric disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Aspartate aminotransferase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0016 affected6 at risk
EG0024 affected7 at risk
EG0030 affected1 at risk
EG004
Blood creatine phosphokinase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG0023 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG0022 affected7 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0023 affected7 at risk
EG003
Lipase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0014 affected6 at risk
EG0021 affected7 at risk
EG003
Amylase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0013 affected6 at risk
EG0021 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Aldolase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Blood pressure increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Heart rate increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Weight increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Fatigue
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0023 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Chills
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Asthenia
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Influenza like illness
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Pain
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0023 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0021 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0024 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0020 affected7 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0021 affected7 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0003 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Lung infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected7 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Dementia
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Dry eye
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hot flush
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Embolism
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Thyroiditis acute
Endocrine disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Prostatic obstruction
Reproductive system and breast disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gait disturbance
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Performance status decreased
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Catheter site pain
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chest discomfort
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chest pain
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Early satiety
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Face oedema
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Localised oedema
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Malaise
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Temperature intolerance
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Thirst
General disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
International normalised ratio increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Ammonia increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood sodium decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Troponin increased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urine output decreased
Investigations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Somnolence
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Akathisia
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dysgraphia
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tremor
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Candida infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Skin infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Flushing
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Phlebitis
Vascular disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blepharitis
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Eye swelling
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Peritoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA version 21.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG002
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0001
OG0011
OG0020
OG0030
OG0041
OG0050
Title
Denominators
Categories
Title
Measurements
OG00029.2(NA to NA)Upper and lower limit of confidence interval (CI) not reached due to less number of participants with events.
OG0013.1(NA to NA)Upper and lower limit of CI not reached due to less number of participants with events.
OG0042.4(NA to NA)Upper and lower limit of CI not reached due to less number of participants with events.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Title
Measurements
OG00014.7(5.2 to NA)Upper limit of CI not reached due to less number of participants with events.
OG0017.4(2.1 to 14.1)
OG0026.5(1.0 to NA)Upper limit of CI not reached due to less number of participants with events.
OG00312.4(3.6 to NA)Upper limit of CI not reached due to less number of participants with events.
OG0042.2(1.5 to 4.9)
OG005NA(5.3 to NA)Median and upper limit of CI not reached due to less number of participants with events.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(0.4 to 64.1)
OG0020.0(0.0 to 41.0)
OG0030.0(0.0 to 17.6)
OG0043.7(0.1 to 19.0)
OG0050.0(0.0 to 28.5)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Title
Measurements
OG0003.0(1.4 to 16.1)
OG0012.5(1.4 to 7.1)
OG0021.3(0.5 to 1.5)
OG0031.5(1.3 to 4.3)
OG0041.3(0.9 to 2.7)
OG0052.5(1.2 to NA)Upper limit of CI not reached due to less number of participants with events.
OG00011
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00010
Title
Measurements
OG000578.6± 626.3302643
Cycle 1 Day 8
ParticipantsOG00011
Title
Measurements
OG000803.3181818± 808.9155788
Cycle 1 Day 15
ParticipantsOG0009
Title
Measurements
OG0001279.833333± 1298.144638
Cycle 2 Day 1
ParticipantsOG00010
Title
Measurements
OG0001485.6± 1368.310653
Cycle 3 Day 1
ParticipantsOG0005
Title
Measurements
OG0001558.4± 1502.22728
Cycle 4 Day 1
ParticipantsOG0001
Title
Measurements
OG0001980± NASince only 1 evaluable participant, standard deviation could not be calculated.
Cycle 5 Day 1
ParticipantsOG0001
Title
Measurements
OG000778± NASince only 1 evaluable participant, standard deviation could not be calculated.
Cycle 6 Day 1
ParticipantsOG0001
Title
Measurements
OG0001730± NASince only 1 evaluable participant, standard deviation could not be calculated.
Cycle 7 Day 1
ParticipantsOG0001
Title
Measurements
OG0002080± NASince only 1 evaluable participant, standard deviation could not be calculated.
Treatment discontinuation
ParticipantsOG0006
Title
Measurements
OG0001743.833333± 1817.18193
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Albumin (grams per liter [g/L]), Hypo: All Grades
Title
Measurements
OG0004
OG0012
OG0024
OG0035
OG00410
OG0052
Albumin (g/L), Hypo: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0021
OG003
Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades
Title
Measurements
OG0005
OG0013
OG0024
OG003
Alkaline Phosphatase (U/L), Hyper: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0020
OG003
Alanine Aminotransferase (U/L), Hyper: All Grades
Title
Measurements
OG0002
OG0013
OG0024
OG003
Alanine Aminotransferase (U/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0011
OG0021
OG003
Amylase (U/L), Hyper: All Grades
Title
Measurements
OG0003
OG0014
OG0022
OG003
Amylase (U/L), Hyper: Grade 3/4
Title
Measurements
OG0002
OG0010
OG0020
OG003
Aspartate Aminotransferase (U/L), Hyper: All Grades
Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades
Title
Measurements
OG0001
OG0010
OG0021
OG003
Bilirubin (umol/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0021
OG003
Calcium (millimoles per liter [mmol/L]), Hypo: All Grades
Title
Measurements
OG0001
OG0011
OG0021
OG003
Calcium (mmol/L), Hypo: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium (mmol/L), Hyper: All Grades
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium (mmol/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatine Kinase (U/L), Hyper: All Grades
Title
Measurements
OG0005
OG0015
OG0025
OG003
Creatine Kinase (U/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0012
OG0021
OG003
Creatinine (umol/L), Hyper: All Grades
Title
Measurements
OG0002
OG0012
OG0021
OG003
Creatinine (umol/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose (mmol/L), Hypo: All Grades
Title
Measurements
OG0000
OG0011
OG0020
OG003
Glucose (mmol/L), Hypo: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose (mmol/L), Hyper: All Grades
Title
Measurements
OG0001
OG0011
OG0021
OG003
Glucose (mmol/L), Hyper: Grade 3/4
Title
Measurements
OG0001
OG0011
OG0021
OG003
Potassium (mmol/L), Hypo: All Grades
Title
Measurements
OG0001
OG0012
OG0023
OG003
Potassium (mmol/L), Hypo: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0020
OG003
Potassium (mmol/L), Hyper: All Grades
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium (mmol/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase (U/L), Hyper: All Grades
Title
Measurements
OG0005
OG0014
OG0023
OG003
Lipase (U/L), Hyper: Grade 3/4
Title
Measurements
OG0002
OG0012
OG0020
OG003
Magnesium (mmol/L), Hypo: All Grades
Title
Measurements
OG0000
OG0011
OG0020
OG003
Magnesium (mmol/L), Hypo: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium (mmol/L), Hyper: All Grades
Title
Measurements
OG0002
OG0011
OG0022
OG003
Magnesium (mmol/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Phosphate (mmol/L), Hypo: All Grades
Title
Measurements
OG0001
OG0013
OG0020
OG003
Phosphate (mmol/L), Hypo: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0020
OG003
Sodium (mmol/L), Hypo: All Grades
Title
Measurements
OG0003
OG0012
OG0023
OG003
Sodium (mmol/L), Hypo: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sodium (mmol/L), Hyper: All Grades
Title
Measurements
OG0003
OG0010
OG0020
OG003
Sodium (mmol/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Hemoglobin (g/L), Hypo: All Grades
Title
Measurements
OG0003
OG0014
OG0025
OG00312
OG0049
OG0057
Hemoglobin (g/L), Hypo: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hemoglobin (g/L), Hyper: All Grades
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin (g/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes (10^9/L), Hypo: All Grades
Title
Measurements
OG0002
OG0011
OG0023
OG003
Lymphocytes (10^9/L), Hypo: Grade 3/4
Title
Measurements
OG0002
OG0011
OG0022
OG003
Lymphocytes (10^9/L), Hyper: All Grades
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes (10^9/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils (10^9/L), Hypo: All Grades
Title
Measurements
OG0001
OG0013
OG0020
OG003
Neutrophils (10^9/L), Hypo: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelets (10^9/L), Hypo: All Grades
Title
Measurements
OG0001
OG0011
OG0022
OG003
Platelets (10^9/L), Hypo: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocytes (10^9/L), Hypo: All Grades
Title
Measurements
OG0002
OG0011
OG0023
OG003
Leukocytes (10^9/L), Hypo: Grade 3/4
Title
Measurements
OG0001
OG0010
OG0020
OG003
Leukocytes (10^9/L), Hyper: All Grades
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocytes (10^9/L), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Activated Partial Thromboplastin Time (sec), Hyper: All Grades
Title
Measurements
OG0002
OG0012
OG0022
OG003
Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4
Title
Measurements
OG0000
OG0010
OG0021
OG003
Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades
Title
Measurements
OG0001
OG0013
OG0022
OG003
Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Alanine Aminotransferase: >3*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0012
OG0022
OG003
Alanine Aminotransferase: >5*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Alanine Aminotransferase: >8*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Alanine Aminotransferase: >10*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Alanine Aminotransferase: >20*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Alkaline Phosphatase: >2*ULN
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00318
Alkaline Phosphatase: >3*ULN
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00319
Aspartate Aminotransferase: >3*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Aspartate Aminotransferase: >5*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Aspartate Aminotransferase: >8*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Aspartate Aminotransferase: >10*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Aspartate Aminotransferase: >20*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Bilirubin: >1.5*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00319
Bilirubin: >2*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST: AT >3*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST: AT >5*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST: AT >8*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST: AT >10*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST: AT >20*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
ALP >3*ULN and Total Bilirubin >2*ULN
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Triiodothyronine, Free: Low (at baseline) to Low (at post baseline)
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0036
ParticipantsOG0049
ParticipantsOG0054
Title
Measurements
OG0000
OG0011
OG0021
OG003
Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline)
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Triiodothyronine, Free: Low (at baseline) to High (at post baseline)
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline)
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Triiodothyronine, Free: Normal (at baseline) to High (at post baseline)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Triiodothyronine, Free: High (at baseline) to Low (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Triiodothyronine, Free: High (at baseline) to Normal (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Triiodothyronine, Free: High (at baseline) to High (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Triiodothyronine, Free: High (at baseline) to Missing (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: Low (at baseline) to Low (at post baseline)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: Low (at baseline) to Normal (at post baseline)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: Low (at baseline) to High (at post baseline)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: Low (at baseline) to Missing (at post baseline)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: Normal (at baseline) to Low (at post baseline)
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG003
Thyroxine, Free: Normal (at baseline) to Normal (at post baseline)
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG003
Thyroxine, Free: Normal (at baseline) to High (at post baseline)
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG003
Thyroxine, Free: Normal (at baseline) to Missing (at post baseline)
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG003
Thyroxine, Free: High (at baseline) to Low (at post baseline)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: High (at baseline) to Normal (at post baseline)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: High (at baseline) to High (at post baseline)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyroxine, Free: High (at baseline) to Missing (at post baseline)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyrotropin: Low (at baseline) to Low (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyrotropin: Low (at baseline) to Normal (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyrotropin: Low (at baseline) to High (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyrotropin: Low (at baseline) to Missing (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Thyrotropin: Normal (at baseline) to Low (at post baseline)
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Thyrotropin: Normal (at baseline) to Normal (at post baseline)
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Thyrotropin: Normal (at baseline) to High (at post baseline)
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Thyrotropin: Normal (at baseline) to Missing (at post baseline)
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG003
Thyrotropin: High (at baseline) to Low (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Thyrotropin: High (at baseline) to Normal (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Thyrotropin: High (at baseline) to High (at post baseline)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Thyrotropin: High (at baseline) to Missing (at post baseline)
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG00317
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00010.6± 750
OG001NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG00317
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00019.5± 667
OG001NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00319
OG00427
OG00511
Title
Denominators
Categories
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG00317
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00014.6± 835
OG001NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG003
Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort
Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
OG005
Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0036
OG0044
OG0055
Title
Denominators
Categories
Cycle 2 Day 1 ARRY-382 RAUC
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0003.03± 47.9
OG0011.92± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0023.52± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003
Cycle 2 Day 1 ARRY-382 RCmax
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Cycle 2 Day 1 AR00469099 RAUC
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
Cycle 2 Day 1 AR00469099 RCmax
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Cycle 2 Day 1 AR00469100 RCmax
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Cycle 2 Day 1 AR00469100 RAUC
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Cycle 2 Day 1 AR00470870 RAUC
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
Cycle 2 Day 1 AR00470870 RCmax
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0062 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
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EG0072 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0041 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0041 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0063 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0063 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0052 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0062 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0071 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0051 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
0 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0061 affected27 at risk
EG0070 affected11 at risk
1 affected
1 at risk
EG0040 affected2 at risk
EG0050 affected19 at risk
EG0060 affected27 at risk
EG0070 affected11 at risk
8
OG00415
OG0055
0
OG0043
OG0050
11
OG00417
OG0056
0
OG0044
OG0050
8
OG00412
OG0057
2
OG0041
OG0053
11
OG0047
OG0057
3
OG0041
OG0051
17
OG00423
OG00511
4
OG0045
OG0052
3
OG0047
OG0051
0
OG0043
OG0050
1
OG0040
OG0052
0
OG0040
OG0050
1
OG0041
OG0050
0
OG0040
OG0050
16
OG00420
OG0057
3
OG0042
OG0052
7
OG0046
OG0052
1
OG0040
OG0050
3
OG0041
OG0050
1
OG0040
OG0050
0
OG0040
OG0052
0
OG0040
OG0052
7
OG0046
OG0054
2
OG0041
OG0050
1
OG0044
OG0051
0
OG0040
OG0050
8
OG0042
OG0055
7
OG0040
OG0052
5
OG0044
OG0053
0
OG0040
OG0050
3
OG0045
OG0050
0
OG0040
OG0050
6
OG0047
OG0052
2
OG0042
OG0050
8
OG00413
OG0056
0
OG0045
OG0051
4
OG0040
OG0050
0
OG0040
OG0050
4
OG0042
OG0052
0
OG0040
OG0051
0
OG0040
OG0050
11
OG00411
OG0055
5
OG0041
OG0052
0
OG0041
OG0050
0
OG0040
OG0050
1
OG0040
OG0051
1
OG0040
OG0050
2
OG0042
OG0051
1
OG0040
OG0050
4
OG0042
OG0052
1
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
6
OG0047
OG0053
2
OG0042
OG0050
9
OG00415
OG0053
2
OG0041
OG0050
3
OG0042
OG0054
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0011
OG0021
OG0032
OG0041
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0041
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0041
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
ParticipantsOG00421
ParticipantsOG00511
Title
Measurements
OG0001
OG0013
OG0022
OG0035
OG00412
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0001
OG0010
OG0021
OG0034
OG0049
OG0051
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0002
OG0013
OG0024
OG0037
OG00413
OG0055
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0001
OG0012
OG0022
OG0034
OG0045
OG0052
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0041
OG0052
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0041
OG0052
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0045
OG0050
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0044
OG0050
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0002
OG0013
OG0024
OG0037
OG00413
OG0055
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0001
OG0012
OG0022
OG0034
OG0045
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0011
OG0021
OG0032
OG0041
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0041
OG0053
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0044
OG0050
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
19
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0043
OG0050
19
ParticipantsOG00425
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
3
OG0043
OG0054
6
ParticipantsOG0049
ParticipantsOG0054
Title
Measurements
OG0001
OG0010
OG0020
OG0033
OG0043
OG0050
6
ParticipantsOG0049
ParticipantsOG0054
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
6
ParticipantsOG0049
ParticipantsOG0054
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0043
OG0050
13
ParticipantsOG00418
ParticipantsOG0057
Title
Measurements
OG0001
OG0010
OG0022
OG0030
OG0044
OG0050
13
ParticipantsOG00418
ParticipantsOG0057
Title
Measurements
OG0003
OG0012
OG0023
OG00312
OG00412
OG0057
13
ParticipantsOG00418
ParticipantsOG0057
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0040
OG0050
13
ParticipantsOG00418
ParticipantsOG0057
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0050
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0010
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0011
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0010
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0010
1
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG0030
OG0042
1
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG0031
OG0040
1
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG0030
OG0040
1
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG0030
OG0041
15
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
15
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0003
OG0012
OG0026
OG00312
OG00418
OG0058
15
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0001
OG0013
OG0020
OG0033
OG0040
OG0052
15
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0044
OG0050
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0030
OG0040
OG0050
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0031
OG0040
OG0050
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0001
OG0011
OG0032
OG0042
OG0051
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0030
OG0040
OG0050
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0010
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0011
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0010
0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0010
18
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
18
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0002
OG0014
OG0025
OG00314
OG00412
OG0055
18
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0003
OG0010
OG0020
OG0034
OG0045
OG0055
18
ParticipantsOG00422
ParticipantsOG00510
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0045
OG0050
1
ParticipantsOG0045
ParticipantsOG0051
Title
Measurements
OG0010
OG0020
OG0030
OG0040
OG0050
1
ParticipantsOG0045
ParticipantsOG0051
Title
Measurements
OG0010
OG0021
OG0030
OG0040
OG0051
1
ParticipantsOG0045
ParticipantsOG0051
Title
Measurements
OG0011
OG0020
OG0031
OG0045
OG0050
1
ParticipantsOG0045
ParticipantsOG0051
Title
Measurements
OG0010
OG0021
OG0030
OG0040
OG0050
1
OG0042
OG0051
Participants
OG004
23
ParticipantsOG00511
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
Participants
OG004
23
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
Participants
OG004
23
ParticipantsOG00511
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
ParticipantsOG00421
ParticipantsOG00511
Title
Measurements
OG0000
OG0011
OG0022
OG0032
OG0042
OG0050
Participants
OG004
23
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG00422
ParticipantsOG00511
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0043
OG0051
ParticipantsOG00420
ParticipantsOG00511
Title
Measurements
OG0004
OG0011
OG0022
OG0033
OG0045
OG0051
Participants
OG004
22
ParticipantsOG00511
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0042
OG0050
Participants
OG004
22
ParticipantsOG00511
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
664
± 194
OG004373± 282
OG005695± 145
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG000542± 78.8
OG001497± 201
OG002827± 64.2
OG0031060± 65.8
OG004982± 101
OG0051160± 57.2
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG000530± 37.9
OG001845± 49.0
OG0021130± 50.0
OG0031010± 44.7
OG004976± 72.6
OG005937± 54.5
ParticipantsOG00426
ParticipantsOG0058
Title
Measurements
OG000384± 26.3
OG001566± 28.8
OG002757± 46.8
OG003683± 43.7
OG004662± 76.7
OG005500± 52.6
ParticipantsOG00416
ParticipantsOG0057
Title
Measurements
OG000616± 43.0
OG001533± 34.2
OG002888± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003862± 57.3
OG004918± 79.1
OG005485± 117
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000576± 59.5
OG001762± 6.44
OG0021040± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003330± 2050
OG0041550± 18.8
OG005438± 86.5
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG0001170± 76.5
OG0011310± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0021430± 195
OG0031320± 97.5
OG0042000± 14.3
OG0051220± 64.2
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0001530± 45.2
OG0011600± 106
OG0022560± 117
OG0031830± 92.2
OG0043000± 9.01
OG0051580± 79.6
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG0001200± 57.6
OG0012030± 35.1
OG0022120± 126
OG0031630± 66.6
OG0042900± 4.73
OG0051450± 62.7
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG0001100± 35.7
OG0011680± 8.22
OG0021440± 142
OG0031530± 52.3
OG0042150± 7.22
OG005973± 75.5
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG000565± 39.5
OG001305± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG003554± 70.3
OG004324± 391
OG005336± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
ParticipantsOG0044
ParticipantsOG0051
Title
Measurements
OG000405± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0031080± 119
OG004728± 85.2
OG005522± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG000NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
OG00392.6± 13300
OG0041000± 35.1
OG00576.6± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG003798± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG0041100± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG005518± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG003573± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG005505± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG003424± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG003350± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG003244± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
21.0
± 234
OG0047.95± 493
OG00522.6± 164
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00036.3± 219
OG00119.6± 495
OG00257.2± 151
OG00366.2± 80.5
OG00454.7± 177
OG00560.8± 52.9
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00069.5± 128
OG00183.6± 69.2
OG002170± 72.6
OG003110± 48.9
OG004113± 109
OG00589.1± 39.5
ParticipantsOG00426
ParticipantsOG0058
Title
Measurements
OG00074.9± 85.3
OG00196.4± 62.9
OG002205± 88.7
OG003119± 49.5
OG004132± 101
OG00575.7± 41.6
ParticipantsOG00416
ParticipantsOG0057
Title
Measurements
OG000136± 30.8
OG00173.7± 62.1
OG002190± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003210± 78.8
OG004250± 172
OG00583.3± 132
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000136± 67.7
OG001199± 82.5
OG002188± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG00396.5± 2860
OG004511± 189
OG00577.1± 85.2
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000133± 72.0
OG001245± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG002177± 94.7
OG003254± 29.2
OG004475± 173
OG005102± 68.2
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG000166± 66.0
OG001166± 133
OG002241± 73.8
OG003272± 36.2
OG004510± 174
OG005133± 54.1
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000177± 89.6
OG001208± 129
OG002305± 62.0
OG003298± 55.6
OG004544± 168
OG005157± 50.7
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000210± 57.5
OG001320± 71.9
OG002313± 77.8
OG003324± 44.1
OG004561± 152
OG005146± 58.5
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG000121± 81.8
OG00131.0± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG003123± 210
OG00470.6± 243
OG00554.0± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
ParticipantsOG0044
ParticipantsOG0051
Title
Measurements
OG00079.9± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003157± 228
OG004138± 30.0
OG00570.3± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG000NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
OG00311.5± 4020
OG004170± 10.4
OG0057.92± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG00386.9± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG004141± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG005110± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG00361.5± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG005103± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00342.7± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00330.6± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00327.0± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
61.0
± 337
OG00421.3± 553
OG00575.4± 131
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00047.1± 109
OG00143.0± 468
OG00271.0± 96.9
OG003114± 69.1
OG00481.9± 150
OG005123± 51.2
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00041.7± 79.2
OG00182.7± 55.7
OG002110± 40.5
OG003102± 62.0
OG00485.5± 84.8
OG005101± 46.8
ParticipantsOG00426
ParticipantsOG0058
Title
Measurements
OG00028.2± 71.2
OG00153.9± 42.5
OG00267.7± 40.5
OG00365.4± 64.8
OG00456.4± 83.3
OG00544.0± 50.5
ParticipantsOG00416
ParticipantsOG0057
Title
Measurements
OG00070.7± 81.2
OG00169.4± 24.5
OG002116± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003106± 94.1
OG00496.0± 85.3
OG00560.8± 121
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG00060.1± 103
OG001107± 45.5
OG002146± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG00335.2± 977
OG004184± 91.1
OG00557.1± 99.2
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000105± 98.3
OG001169± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG002138± 228
OG003116± 75.2
OG004191± 92.5
OG005173± 39.1
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG000138± 81.9
OG001196± 81.9
OG002268± 141
OG003165± 81.7
OG004265± 65.5
OG005226± 66.5
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000108± 108
OG001228± 39.5
OG002219± 131
OG003139± 57.4
OG004264± 75.1
OG005164± 67.5
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000104± 75.9
OG001210± 27.1
OG002161± 158
OG003124± 39.5
OG004218± 74.8
OG005107± 77.8
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00063.2± 108
OG00157.3± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG00373.2± 73.5
OG00454.8± 255
OG00532.7± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
ParticipantsOG0044
ParticipantsOG0051
Title
Measurements
OG00031.1± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003108± 109
OG00475.5± 88.7
OG00567.6± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG000NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
OG00314.0± 6560
OG004112± 46.2
OG00511.7± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG003110± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG004148± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG00572.8± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG00373.2± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG00567.4± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00351.3± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00344.0± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00333.8± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
46.9
± 403
OG00412.6± 1100
OG00571.7± 125
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00049.4± 193
OG00136.7± 2940
OG00268.7± 113
OG003140± 97.9
OG00474.8± 277
OG005189± 59.5
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00064.5± 101
OG001159± 106
OG002182± 73.7
OG003191± 59.9
OG004129± 116
OG005220± 46.9
ParticipantsOG00426
ParticipantsOG0058
Title
Measurements
OG00053.7± 78.4
OG001144± 71.3
OG002162± 52.6
OG003150± 56.8
OG004123± 90.1
OG005148± 46.7
ParticipantsOG00416
ParticipantsOG0057
Title
Measurements
OG000105± 86.9
OG001255± 11.0
OG002231± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003259± 49.3
OG004307± 74.0
OG005242± 33.5
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG00099.1± 80.8
OG001294± 49.3
OG002216± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG00383.4± 2600
OG004285± 58.4
OG005224± 34.1
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000122± 63.9
OG001377± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG002206± 68.5
OG003244± 58.1
OG004279± 53.8
OG005316± 26.4
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG000165± 49.3
OG001444± 29.0
OG002283± 68.8
OG003337± 70.2
OG004310± 47.2
OG005462± 16.9
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000149± 54.4
OG001503± 26.8
OG002327± 61.2
OG003320± 65.9
OG004348± 40.3
OG005486± 18.9
ParticipantsOG0043
ParticipantsOG0055
Title
Measurements
OG000151± 58.9
OG001460± 37.6
OG002306± 47.9
OG003337± 55.3
OG004345± 36.1
OG005401± 19.2
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG000118± 88.7
OG001250± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG003156± 87.0
OG004194± 65.0
OG005194± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
ParticipantsOG0044
ParticipantsOG0051
Title
Measurements
OG00077.4± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG003161± 113
OG004263± 13.5
OG005158± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG000NA± NASince concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.
OG00316.4± 10600
OG004268± 18.2
OG00533.8± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG00373.5± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG004419± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG005192± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG00360.7± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
OG005236± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00362.8± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00373.8± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00390.6± NADue to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
7920
± 18.9
OG00414200± 123
OG0052840± 61.8
2670
± 53.4
OG0045360± 62.8
OG0052480± 73.9
6850
± 61.2
OG0047940± 36.9
OG0058220± 20.3
1240
± 62.1
OG0041290± 75.6
OG0051260± 53.9
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0001560± 41.3
OG0012260± 36.6
OG0022560± 117
OG0032130± 60.4
OG0042820± 15.1
OG0051580± 64.8
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00084.0± 102
OG001100± 59.8
OG002219± 83.8
OG003119± 50.9
OG004142± 97.9
OG00595.4± 43.2
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG000212± 57.3
OG001241± 103
OG002328± 75.6
OG003328± 44.0
OG004646± 111
OG005161± 50.8
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00061.2± 78.3
OG001104± 86.5
OG002122± 41.7
OG003132± 70.0
OG004116± 98.3
OG005138± 46.5
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG000138± 81.6
OG001257± 36.4
OG002268± 141
OG003181± 56.9
OG004279± 54.9
OG005215± 52.5
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG00070.1± 95.1
OG001174± 92.5
OG002196± 58.5
OG003193± 60.5
OG004147± 98.9
OG005231± 50.8
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG000172± 51.6
OG001534± 22.0
OG002333± 60.7
OG003373± 60.6
OG004363± 30.9
OG005486± 18.9
277
± 27.1
OG004557± 136
OG00577.1± 85.2
82.4
± 57.1
OG004193± 71.3
OG00557.1± 99.2
232
± 58.5
OG004302± 48.1
OG005224± 34.1
1.97
(0.950 to 4.17)
OG0042.00(0.967 to 8.00)
OG0052.00(1.00 to 4.10)
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0002.00(2.00 to 7.95)
OG0014.18(1.85 to 7.48)
OG0021.98(1.97 to 2.00)
OG0032.00(1.00 to 7.50)
OG0043.03(2.00 to 4.08)
OG0052.00(1.83 to 4.17)
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0007.98(4.00 to 8.02)
OG0017.81(3.97 to 8.00)
OG0027.95(4.00 to 8.02)
OG0035.88(3.98 to 8.00)
OG0045.83(1.92 to 8.03)
OG0054.17(2.00 to 8.00)
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0007.94(4.10 to 8.05)
OG0017.68(3.85 to 8.00)
OG0028.00(4.00 to 8.00)
OG0037.50(4.00 to 8.00)
OG0045.90(0.00 to 8.00)
OG0054.05(2.00 to 7.50)
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0002.00(1.00 to 4.07)
OG0012.98(1.25 to 4.05)
OG0024.07(0.983 to 8.00)
OG0032.00(1.00 to 4.17)
OG0042.00(0.967 to 8.02)
OG0052.00(1.00 to 4.10)
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0002.00(2.00 to 7.95)
OG0013.03(1.85 to 7.48)
OG0021.98(1.97 to 2.00)
OG0031.98(1.00 to 7.50)
OG0043.90(2.00 to 4.03)
OG0052.00(0.917 to 3.75)
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0003.00(2.00 to 8.02)
OG0014.03(1.83 to 8.00)
OG0024.07(4.00 to 8.00)
OG0034.00(2.00 to 7.58)
OG0044.07(1.92 to 8.02)
OG0053.80(1.88 to 4.15)
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0003.00(2.00 to 7.95)
OG0014.18(1.85 to 7.48)
OG0028.00(4.00 to 8.00)
OG0034.03(1.95 to 7.50)
OG0045.78(4.00 to 8.00)
OG0054.05(3.75 to 4.17)
0.101
± 45.7
OG0040.108± 63.4
OG0050.0821± 31.3
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0000.106± 58.8
OG0010.0979± 74.9
OG0020.160± 79.5
OG0030.0929± 46.5
OG0040.107± 71.8
OG0050.0734± 38.3
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0000.177± 35.6
OG0010.144± 80.3
OG0020.186± 84.6
OG0030.240± 69.0
OG0040.292± 132
OG0050.134± 27.5
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0000.132± 20.5
OG0010.103± 68.2
OG0020.125± 74.8
OG0030.150± 89.9
OG0040.222± 108
OG0050.0991± 24.0
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0000.0817± 40.7
OG0010.101± 33.4
OG0020.0934± 31.0
OG0030.104± 39.3
OG0040.0883± 41.2
OG0050.108± 22.9
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0000.0811± 45.0
OG0010.107± 35.0
OG0020.0941± 21.8
OG0030.109± 47.2
OG0040.0923± 41.3
OG0050.112± 29.8
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0000.0978± 43.8
OG0010.129± 27.1
OG0020.117± 13.1
OG0030.0853± 13.8
OG0040.117± 66.4
OG0050.123± 40.8
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0000.0909± 41.4
OG0010.116± 29.3
OG0020.108± 24.5
OG0030.0873± 19.2
OG0040.101± 52.8
OG0050.140± 44.3
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0000.0946± 104
OG0010.159± 42.7
OG0020.127± 44.9
OG0030.151± 71.1
OG0040.106± 64.0
OG0050.176± 72.4
ParticipantsOG00426
ParticipantsOG00511
Title
Measurements
OG0000.0775± 119
OG0010.149± 26.6
OG0020.126± 30.4
OG0030.133± 78.0
OG0040.0974± 51.4
OG0050.156± 71.6
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0000.119± 80.2
OG0010.273± 43.1
OG0020.172± 66.7
OG0030.182± 69.3
OG0040.144± 41.1
OG0050.340± 59.0
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0000.0941± 84.4
OG0010.201± 36.1
OG0020.111± 42.7
OG0030.150± 66.6
OG0040.110± 31.3
OG0050.263± 59.6
2.67
± 36.2
OG0043.41± 23.6
OG0051.87± 16.7
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0002.53± 48.2
OG0012.51± 95.7
OG0022.28± 54.2
OG0032.52± 39.9
OG0042.07± 53.6
OG0051.62± 24.7
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0004.03± 93.0
OG0014.36± NASince only 1 evaluable participant, geometric coefficient of variation could not be calculated.
OG0024.28± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0034.67± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0044.95± 41.8
OG0052.07± 23.8
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0003.03± 53.4
OG0012.54± 52.0
OG0022.47± 38.5
OG0033.19± 36.7
OG0043.56± 48.4
OG0051.93± 37.4
ParticipantsOG0044
ParticipantsOG0055
Title
Measurements
OG0002.67± 46.1
OG0012.60± 157
OG0022.50± 65.1
OG0032.44± 41.3
OG0042.08± 49.0
OG0051.76± 29.5
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0003.49± 51.7
OG0011.97± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0023.96± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0032.64± 36.3
OG0043.84± 13.5
OG0051.93± 23.0
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0003.47± 94.9
OG0014.48± NASince only 1 evaluable participant, geometric coefficient of variation could not be calculated.
OG0022.73± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
OG0034.01± NAAs planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.