Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Ba... | NCT03307785 | Trialant
NCT03307785
Sponsor
Tesaro, Inc.
Status
Completed
Last Update Posted
Nov 25, 2025Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Neoplasms
Metastatic Cancer
Advanced Cancer
Solid Tumor
Non Small Cell Lung Cancer Metastatic
Non Small Cell Lung Cancer Stage IIIB
Non Small Cell Lung Cancer
Interventions
Niraparib
TSR-042
Carboplatin-Paclitaxel
Bevacizumab
TSR-022
Carboplatin-Pemetrexed
Carboplatin-Nab-Paclitaxel
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03307785
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
213351
Secondary IDs
ID
Type
Description
Link
3000-01-002
Other Identifier
Tesaro
Brief Title
Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042
Official Title
Phase 1b Dose-Finding Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 in Patients With Advanced or Metastatic Cancer
Acronym
Not provided
Organization
Tesaro, Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 12, 2017Actual
Primary Completion Date
Feb 26, 2020Actual
Completion Date
Dec 11, 2024Actual
First Submitted Date
Sep 26, 2017
First Submission Date that Met QC Criteria
Oct 6, 2017
First Posted Date
Oct 12, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2021
Results First Submitted that Met QC Criteria
Apr 14, 2021
Results First Posted Date
May 10, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 10, 2025
Last Update Posted Date
Nov 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tesaro, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part B: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.
Part D: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.
Part E: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part F: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part G: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part H: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part I: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Metastatic Cancer
Advanced Cancer
Solid Tumor
Non Small Cell Lung Cancer Metastatic
Non Small Cell Lung Cancer Stage IIIB
Non Small Cell Lung Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: TSR-042 and niraparib 200 mg QD
Experimental
Patients will receive TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
Drug: Niraparib
Drug: TSR-042
Part A: TSR-042 and niraparib 300 mg QD
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Drug: Niraparib
Drug: TSR-042
Part B: TSR-042 and carboplatin-paclitaxel
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Drug: TSR-042
Drug: Carboplatin-Paclitaxel
Part C: TSR-042, niraparib 200 mg QD and bevacizumab
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Niraparib
Drug
Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Dose-limiting Toxicity (DLT)
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
21 days
Part B: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
21 days
Part C: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Secondary Outcomes
Measure
Description
Time Frame
Part A: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient has histologically or cytologically proven advanced (unresectable) or metastatic cancer as outlined below according to study part and disease type:
Part A: Patients with previously treated advanced or metastatic cancer. Patient may have received no more than 4 lines of treatment for advanced or metastatic cancer. Hormonal treatment will not be considered a prior line of treatment.
Part B: Patients with advanced or metastatic cancer for which treatment with carboplatin-paclitaxel is considered appropriate therapy. Patient may have received no more than 1 prior line of chemotherapy in the metastatic setting. Hormonal treatment will not be considered a prior line of treatment.
Part C: Patients with previously treated advanced or metastatic cancer. Patient may have received no more than 4 lines of treatment for advanced or metastatic cancer. Hormonal treatment will not be considered a prior line of treatment.
Part D: Patients in whom carboplatin-paclitaxel and bevacizumab is considered appropriate therapy. Patient may have received no more than 1 prior line of chemotherapy in the metastatic setting. Hormonal treatment will not be considered a prior line of treatment.
Part E and F: Patients who have not received prior systemic therapy, including targeted therapy and biologic agents, for their advanced or metastatic (Stage ≥ IIIB or IV) Non-Squamous NSCLC. Patients who have received neoadjuvant or adjuvant therapy are eligible as long as development of advanced or metastatic disease occurred at least 12 months after completion of neoadjuvant or adjuvant therapy.
Part G, H, and I: Patients who have not received prior systemic therapy, including targeted therapy and biologic agents, for their advanced or metastatic (Stage ≥ IIIB or IV) NSCLC. Patients who have received neoadjuvant or adjuvant therapy are eligible as long as development of advanced or metastatic disease occurred at least 12 months after completion of neoadjuvant or adjuvant therapy.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Patient has adequate organ function.
Female patient has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential.
Male patient agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study treatment through 90 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
Patient has measurable lesions by RECIST v1.1.
For Part A and C, in addition to the general inclusion criteria, patients must also meet the following additional criterion to be considered eligible to participate in this study:
Patient is able to take oral medications.
For patients to be eligible for any parts of the study using niraparib 300 mg as a starting dose, a screening actual body weight ≥ 77 kg and screening platelet count ≥ 150,000 u/L is necessary.
Exclusion Criteria: (Patients will not be eligible for the study entry if any of the following criteria are met)
Patient has known active central nervous system metastases, carcinomatous meningitis, or both.
Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection that requires systemic therapy.
Patient has a condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation
Patient is pregnant or expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment.
Note: No data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in breastfed infants from niraparib, female patients should not breastfeed during treatment with niraparib and for 1 month after receiving the final dose.
Patient has a known history of human immunodeficiency virus (type 1 or 2 antibodies).
Patient has known active hepatitis B or hepatitis C.
Patient has an active autoimmune disease that has required systemic treatment in the past 2 years.
Patient has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Patient has undergone prior treatment with a known PARP inhibitor.
Known history or current diagnosis of MDS or AML.
Patient has a known hypersensitivity to TSR-042 components or excipients.
For Parts B, D, E, F, G, H, and I, patients will not be eligible for study entry if any of the following additional exclusion criterion are met:
• Patient has a known hypersensitivity to any of the following relevant study treatments: carboplatin, paclitaxel, pemetrexed, nab-paclitaxel, or TSR-022 components or excipients.
For Parts C and D only, patients will not be eligible for study entry if the following additional exclusion criterion is met:
Patient has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident [CVA]) within 6 months of enrollment.
Patient has a history of bowel obstruction, including subocclusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
Patient has proteinuria as demonstrated by urine protein: creatinine ratio ≥1.0 at screening or urine dipstick for proteinuria ≥2 (patients discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate <2 g of protein in 24 hours to be eligible).
Patient is at increased bleeding risk due to concurrent conditions (e.g., major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
Patient has a known hypersensitivity to bevacizumab components or excipients.
For Parts E and F only, patients will not be eligible for study entry if any of the following additional exclusion criteria are met:
Patient is unable to interrupt aspirin or other nonsteroidal ant-inflammatory drugs, other than an aspirin dose ≤ 1.3 g per day, for a 5-day period (8-day period for long -acting agents, such as piroxicam.
Patient is unable or unwilling to take folic acid, vitamin B12 supplement.
Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
For Parts G, H, and I only, patients will not be eligible for study entry if any of the following additional exclusion criteria are met:
• Patient has pre-existing peripheral neuropathy that is Grade ≥ 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.
For Parts E, F, G, H and I only, patients will not be eligible for study entry if any of the following additional exclusion criteria are met:
• Patient has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
Yap TA, Bessudo A, Hamilton E, Sachdev J, Patel MR, Rodon J, Evilevitch L, Duncan M, Guo W, Kumar S, Lu S, Dezube BJ, Gabrail N. IOLite: phase 1b trial of doublet/triplet combinations of dostarlimab with niraparib, carboplatin-paclitaxel, with or without bevacizumab in patients with advanced cancer. J Immunother Cancer. 2022 Mar;10(3):e003924. doi: 10.1136/jitc-2021-003924.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. Main Study Phase was planned to be a nine-part study with Parts A to I. However, Parts G, H and I were not initiated due to business strategic reason. In PACT phase those participants benefiting from treatment continued to receive study drug until discontinuation or withdrawal from study.
Recruitment Details
A total of 60 participants were enrolled in the study and 2 participants who originally signed inform consent form (ICF) withdrew their consent shortly from study before treatment assignment and a total of 58 participants were part of the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
Periods
Title
Milestones
Reasons Not Completed
Main Study: Part A: Up to 28.5 Months
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 15, 2018
Jan 12, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Niraparib
Drug: TSR-042
Drug: Bevacizumab
Part C: TSR-042, niraparib 300 mg QD and bevacizumab
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Drug: Niraparib
Drug: TSR-042
Drug: Bevacizumab
Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Drug: TSR-042
Drug: Carboplatin-Paclitaxel
Drug: Bevacizumab
Part E: TSR-042 and carboplatin-pemetrexed
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for 6 cycles (each cycle is 21 days).
Drug: TSR-042
Drug: Carboplatin-Pemetrexed
Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for 5 cycles (each cycle is 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Drug: TSR-042
Drug: TSR-022
Drug: Carboplatin-Pemetrexed
Part G: TSR-042 and carboplatin-nab-paclitaxel
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Drug: TSR-042
Drug: Carboplatin-Nab-Paclitaxel
Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Drug: TSR-042
Drug: TSR-022
Drug: Carboplatin-Nab-Paclitaxel
Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
Experimental
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days).
Drug: TSR-042
Drug: Carboplatin-Paclitaxel
Drug: TSR-022
Part A: TSR-042 and niraparib 200 mg QD
Part A: TSR-042 and niraparib 300 mg QD
Part C: TSR-042, niraparib 200 mg QD and bevacizumab
Part C: TSR-042, niraparib 300 mg QD and bevacizumab
Zejula
TSR-042
Drug
TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
Part A: TSR-042 and niraparib 200 mg QD
Part A: TSR-042 and niraparib 300 mg QD
Part B: TSR-042 and carboplatin-paclitaxel
Part C: TSR-042, niraparib 200 mg QD and bevacizumab
Part C: TSR-042, niraparib 300 mg QD and bevacizumab
Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
Part E: TSR-042 and carboplatin-pemetrexed
Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
Part G: TSR-042 and carboplatin-nab-paclitaxel
Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
Carboplatin-Paclitaxel
Drug
Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types, including non-small cell lung cancer [NSCLC], ovarian cancer, endometrial cancer, and head and neck cancer.
Part B: TSR-042 and carboplatin-paclitaxel
Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
Bevacizumab
Drug
Bevacizumab is a chemotherapy treatment that has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.
Part C: TSR-042, niraparib 200 mg QD and bevacizumab
Part C: TSR-042, niraparib 300 mg QD and bevacizumab
Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
Avastin
TSR-022
Drug
TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells.
TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth.
Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
Carboplatin-Pemetrexed
Drug
Pemetrexed and platinum therapy in combination with pembrolizumab (anti-PD-1 antibody) has proven to be efficacious in a first line setting for nonsquamous NSCLC patients
Part E: TSR-042 and carboplatin-pemetrexed
Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
Carboplatin-Nab-Paclitaxel
Drug
Nab-paclitaxel is a formulation of paclitaxel that is indicated for locally advanced or metastatic NSCLC, as first-line treatment in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy. Nab-paclitaxel has shown increased ORR and time to progression in metastatic breast cancer compared with solvent-based paclitaxel and has shown antitumor activity and improved ORR compared with solvent-based paclitaxel as first-line therapy in patients with NSCLC.
Part G: TSR-042 and carboplatin-nab-paclitaxel
Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
21 days
Part D: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
21 days
Part E: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
21 days
Part F: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
21 days
Part G: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
21 days
Part H: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
21 days
Part I: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
21 days
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Up to 28.5 months
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Up to 28.5 months
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Up to 22.5 months
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Up to 9.5 months
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Up to 4.4 months
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Up to 3.5 months
Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Up to 24 months
Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Up to 24 months
Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Up to 24 months
Up to 28.5 months
Part B: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 28.5 months
Part C: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 22.5 months
Part D: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 9.5 months
Part E: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 4.4 months
Part F: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 3.5 months
Part G: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 24 months
Part H: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 24 months
Part I: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Up to 24 months
Part A: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to 28.5 months
Part B: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to approximately 66 months
Part C: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to approximately 60 months
Part D: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to approximately 62.5 months
Part E: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to 4.4 months
Part F: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to 3.5 months
Part G: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to 24 months
Part H: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to 24 months
Part I: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Up to 24 months
Part A: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
Up to 28.5 months
Part B: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 28.5 months
Part C: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 22.5 months
Part D: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 9.5 months
Part E: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 4.4 months
Part F: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 3.5 months
Part G: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 24 months
Part H: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 24 months
Part I: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Up to 24 months
Part A: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Up to 28.5 months
Part B: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Up to 28.5 months
Part C: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Up to 22.5 months
Part D: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Up to 9.5 months
Part E: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Up to 4.4 months
Part F: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Up to 3.5 months
Part G: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Up to 24 months
Part H: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Up to 24 months
Part I: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Up to 24 months
Part A: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
Up to 28.5 months
Part B: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 28.5 months
Part C: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 22.5 months
Part D: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 9.5 months
Part E: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 4.4 months
Part F: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 3.5 months
Part F: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 3.5 months
Part G: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 24 months
Part H: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 24 months
Part H: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 24 months
Part I: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 24 months
Part I: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Up to 24 months
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: AUC(0-t) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: AUC0-t of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
FG002
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
FG003
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
FG004
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
FG005
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
FG006
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
FG007
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
FG008
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
FG009
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
FG010
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
FG011
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
FG012
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Disease progression
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0007 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0004 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
MainStudy: PartB: Up to Approx.66months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
MainStudy: PartC:Up to Approx.60months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0036 subjects
FG0047 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
MainStudy:PartD:Up to Approx. 62.5months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Main Study: Part E: Up to 4.4 Months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Main Study: Part F: Up to 3.5 Months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Main Study: Part G: Up to 24 Months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Main Study: Part H: Up to 24 Months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Main Study: Part I: Up to 24 Months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
PACT Phase: Up to 19 Months
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjectsParticipants transitioned from main study phase to PACT Phase.
FG0121 subjectsParticipants transitioned from main study phase to PACT Phase.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Parts G, H and I were not initiated due to business strategic reason. Hence, no participants were enrolled in Parts G, H and I.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
BG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
BG002
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
BG003
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
BG004
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
BG005
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
BG006
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
BG007
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
BG008
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
BG009
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
BG010
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0016
BG00214
BG0036
BG0047
BG0056
BG0062
BG0071
BG0080
BG0090
BG0100
BG01158
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18-64 years
BG0008
BG0013
BG0025
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Black or African American
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A: Number of Participants With Dose-limiting Toxicity (DLT)
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
Safety Population consisted of all participants who received any amount of study treatment.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
Primary
Part B: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Safety Population.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Primary
Part C: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Safety Population.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Primary
Part D: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Safety Population.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Primary
Part E: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Safety Population.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Primary
Part F: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Safety Population.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Primary
Part G: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Safety Population. Data was not collected as no participants were enrolled in Part G.
Posted
21 days
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Primary
Part H: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Safety Population. Data was not collected as no participants were enrolled in Part H.
Posted
21 days
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Primary
Part I: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Safety Population. Data was not collected as no participants were enrolled in Part I.
Posted
21 days
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Primary
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Safety Population.
Posted
Count of Participants
Participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Primary
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Safety Population.
Posted
Count of Participants
Participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Primary
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Safety Population.
Posted
Count of Participants
Participants
Up to 22.5 months
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Primary
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Safety Population.
Posted
Count of Participants
Participants
Up to 9.5 months
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Primary
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Safety Population.
Posted
Count of Participants
Participants
Up to 4.4 months
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
Primary
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Safety Population.
Posted
Count of Participants
Participants
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Primary
Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Safety Population. Data was not collected as no participants were enrolled in Part G.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
Primary
Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Safety Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
Primary
Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Safety Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
Secondary
Part A: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population.
Posted
Number
Percentage of participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population.
Posted
Number
Percentage of participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population.
Posted
Number
Percentage of participants
Up to 22.5 months
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population.
Posted
Number
Percentage of participants
Up to 9.5 months
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population.
Posted
Number
Percentage of participants
Up to 4.4 months
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population.
Posted
Number
Percentage of participants
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population. Data was not collected as no participants were enrolled in Part G.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Safety Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population.
Posted
Median
Full Range
Months
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Units
Counts
Secondary
Part B: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population.
Posted
Median
Full Range
Months
Up to approximately 66 months
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population.
Posted
Median
Full Range
Months
Up to approximately 60 months
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population.
Posted
Median
Full Range
Months
Up to approximately 62.5 months
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population.
Posted
Median
Full Range
Months
Up to 4.4 months
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population.
Posted
Median
Full Range
Months
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population. Data was not collected as no participants were enrolled in Part G.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Safety Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
Safety Population.
Posted
Number
Percentage of participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Units
Counts
Participants
Secondary
Part B: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population.
Posted
Number
Percentage of participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population.
Posted
Number
Percentage of participants
Up to 22.5 months
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population.
Posted
Number
Percentage of participants
Up to 9.5 months
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population.
Posted
Number
Percentage of participants
Up to 4.4 months
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population.
Posted
Number
Percentage of participants
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population. Data was not collected as no participants were enrolled in Part G.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Safety Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Safety Population.
Posted
Median
Inter-Quartile Range
Months
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Safety Population.
Posted
Median
Inter-Quartile Range
Months
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Safety Population.
Posted
Median
Inter-Quartile Range
Months
Up to 22.5 months
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Safety Population.
Posted
Median
Inter-Quartile Range
Months
Up to 9.5 months
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Safety Population.
Posted
Median
Inter-Quartile Range
Months
Up to 4.4 months
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Safety Population.
Posted
Median
Inter-Quartile Range
Months
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Safety Population. Data was not collected as no participants were enrolled in Part G.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Safety Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Safety Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 28.5 months
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 22.5 months
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 9.5 months
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 4.4 months
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population.
Posted
Count of Participants
Participants
Up to 3.5 months
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.
Posted
Up to 24 months
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: AUC(0-t) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: AUC0-t of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: AUC0-t of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: AUC0-t of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: AUC0-t of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: AUC0-t of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: AUC0-t of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: AUC0-t of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*microgram per milliliter
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: AUC(0-infinity) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*microgram per milliliter
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*microgram per milliliter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: AUC(0-infinity) of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: AUC(0-infinity) of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: AUC(0-infinity) of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: AUC(0-infinity) of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: AUC(0-infinity) of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: AUC(0-infinity) of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Ctau of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Ctau of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Ctau of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Ctau of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Ctau of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Ctau of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Ctau of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Maximum Observed Plasma (Cmax) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Units
Counts
Secondary
Part B: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Cmax of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Cmax of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Cmax of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Cmax of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Cmax of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Cmax of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Cmax of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Clearance After Oral Administration (CL/F) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter per hour
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Clearance After Intravenous Administration (CL) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter per hour
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter per hour
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: CL/F of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter per hour
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter per hour
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter per hour
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: CL of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: CL of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: CL of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: CL of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: CL of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: CL of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Vz/F of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Vz of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Vz of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Vz of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Vz of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Vz of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Vz of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: AUC at Steady State (AUCss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: AUCss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Hours*microgram per milliliter
Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: AUCss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: AUCss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: AUCss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: AUCss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: AUCss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: AUCss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Ctau at Steady State (Ctau,ss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Ctau,ss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Ctau,ss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Ctau,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Ctau,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Ctau,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Ctau,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Ctau,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Cmax at Steady State (Cmax,ss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Cmax,ss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Microgram per milliliter
Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Cmax,ss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Cmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Cmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Cmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Cmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Cmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Units
Counts
Secondary
Part B: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Tmax of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Tmax of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Tmax of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Posted
Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Tmax of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Tmax of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Tmax of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Tmax of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Posted
Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Tmax at Steady State (Tmax,ss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Median
Full Range
Hours
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part A: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Median
Full Range
Hours
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Median
Full Range
Hours
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Tmax,ss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Median
Full Range
Hours
Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part C: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Median
Full Range
Hours
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Median
Full Range
Hours
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Median
Full Range
Hours
Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Tmax,ss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Tmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Tmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Tmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Tmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Tmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
OG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Secondary
Part B: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part C: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
OG001
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Secondary
Part D: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Liter
Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG000
Secondary
Part E: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
PK Population.
Posted
Mean
Standard Deviation
Liter
Cycle 2: Pre-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part F: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part F: Vss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Units
Counts
Participants
OG000
Secondary
Part G: Vss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part G.
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Vss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part H: Vss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part H.
Posted
Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
ID
Title
Description
OG000
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Units
Counts
Participants
OG000
Secondary
Part I: Vss of TSR-042
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Secondary
Part I: Vss of TSR-022
Blood samples were planned to be collected at indicated time points.
PK Population. Data was not collected as no participants were enrolled in Part I.
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
Units
Counts
Participants
OG000
Time Frame
All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Description
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
4
16
11
16
16
16
EG001
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
4
6
4
6
6
6
EG002
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
7
14
9
14
14
14
EG003
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
2
6
3
6
5
6
EG004
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
5
7
3
7
7
7
EG005
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
1
6
3
6
6
6
EG006
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
1
2
2
2
2
2
EG007
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
0
1
0
1
1
1
EG008
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
0
2
0
2
0
2
EG009
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
1
1
1
1
0
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Asthenia
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Fatigue
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Mucosal inflammation
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Sudden death
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pneumonia
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Sinusitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Vertebral artery dissection
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
General Medical Deterioration
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG00013 events4 affected16 at risk
EG0019 events3 affected6 at risk
EG00227 events10 affected14 at risk
EG0039 events2 affected6 at risk
EG00410 events5 affected7 at risk
EG00510 events5 affected6 at risk
EG0066 events2 affected2 at risk
EG00712 events1 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events1 affected16 at risk
EG0012 events1 affected6 at risk
EG0029 events6 affected14 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0007 events4 affected16 at risk
EG0012 events2 affected6 at risk
EG0023 events2 affected14 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Palpitations
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Tachycardia
Cardiac disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Blepharitis
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Diplopia
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Ophthalmoplegia
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Vision blurred
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected14 at risk
EG003
Visual impairment
Eye disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0005 events4 affected16 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0005 events5 affected16 at risk
EG0012 events2 affected6 at risk
EG0026 events4 affected14 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0027 events6 affected14 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gastric disorder
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypertrophy of tongue papillae
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG00010 events8 affected16 at risk
EG0015 events4 affected6 at risk
EG0024 events4 affected14 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected14 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG00011 events5 affected16 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Asthenia
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0024 events3 affected14 at risk
EG003
Chest discomfort
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Chest pain
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Chills
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Cyst rupture
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Fatigue
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events4 affected16 at risk
EG0013 events3 affected6 at risk
EG0029 events7 affected14 at risk
EG003
Gait disturbance
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Localised oedema
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Malaise
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Mucosal inflammation
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Oedema peripheral
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0025 events3 affected14 at risk
EG003
Pain
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected14 at risk
EG003
Peripheral swelling
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected14 at risk
EG003
Pyrexia
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0023 events2 affected14 at risk
EG003
Swelling
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Swelling face
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Temperature intolerance
General disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Bacterial vulvovaginitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Candida infection
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0024 events4 affected14 at risk
EG003
Cellulitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Cystitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Dacryocystitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Folliculitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Herpes zoster
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Influenza
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Kidney infection
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lung abscess
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Onychomycosis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pneumonia
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Sepsis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Sinusitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Stoma site infection
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events3 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0026 events4 affected14 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Radiation injury
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Recall phenomenon
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0025 events2 affected14 at risk
EG003
Amylase increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0006 events3 affected16 at risk
EG0011 events1 affected6 at risk
EG0025 events2 affected14 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood bilirubin increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood creatinine increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events2 affected16 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood folate decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Blood potassium decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Blood pressure increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Blood testosterone decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood uric acid increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Breath sounds abnormal
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cardiac murmur
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
International normalised ratio increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Neutrophil count decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Platelet count decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0014 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Tri-iodothyronine decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Vitamin B12 decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Weight decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events4 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Weight increased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
White blood cell count decreased
Investigations
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0026 events5 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0004 events4 affected16 at risk
EG0011 events1 affected6 at risk
EG0024 events4 affected14 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0005 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0008 events5 affected16 at risk
EG0010 events0 affected6 at risk
EG0026 events5 affected14 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0029 events4 affected14 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG00211 events6 affected14 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0024 events2 affected14 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Soft tissue mass
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Autonomic neuropathy
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Balance disorder
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dizziness
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0025 events4 affected14 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected14 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Headache
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events3 affected16 at risk
EG0011 events1 affected6 at risk
EG0023 events3 affected14 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hyperreflexia
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Memory impairment
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Neuralgia
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0026 events4 affected14 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Sciatica
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Somnolence
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Syncope
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Tremor
Nervous system disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Device malfunction
Product Issues
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Device occlusion
Product Issues
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Anxiety
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Confusional state
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Depression
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Disorientation
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Insomnia
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events3 affected16 at risk
EG0012 events2 affected6 at risk
EG0024 events4 affected14 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Bronchial secretion retention
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0005 events4 affected16 at risk
EG0014 events3 affected6 at risk
EG0024 events3 affected14 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0006 events4 affected16 at risk
EG0011 events1 affected6 at risk
EG0027 events6 affected14 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Immune-mediated pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected14 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Upper airway obstruction
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG00210 events8 affected14 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected14 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0006 events4 affected16 at risk
EG0012 events1 affected6 at risk
EG0028 events3 affected14 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hot flush
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypertension
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypotension
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0003 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected14 at risk
EG003
Pallor
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRAv(23.0)v(25.0)
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 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
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
BG007NAData is not reported due to participant confidentiality and privacy concerns.
BG0080
BG0090
BG0100
BG011NATotal not calculated because data are not available (NA) in one or more arms.
Male
BG0007
BG0014
BG0026
BG0032
BG0040
BG0051
BG0062
BG007NAData is not reported due to participant confidentiality and privacy concerns.
BG0080
BG0090
BG0100
BG011NATotal not calculated because data are not available (NA) in one or more arms.
1
BG0030
BG0042
BG0050
BG0061
BG007NAData is not reported due to participant confidentiality and privacy concerns.
BG0080
BG0090
BG0100
BG011NATotal not calculated because data are not available (NA) in one or more arms.
White
BG00016
BG0015
BG00213
BG0036
BG0045
BG0056
BG0061
BG007NAData is not reported due to participant confidentiality and privacy concerns.
BG0080
BG0090
BG0100
BG011NATotal not calculated because data are not available (NA) in one or more arms.
Units
Counts
Participants
OG00014
Title
Denominators
Categories
Title
Measurements
OG0001
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0000
Participants
OG0002
Title
Denominators
Categories
Title
Measurements
OG0000
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG0000
Counts
Participants
OG0000
Units
Counts
Participants
OG0000
Participants
OG0000
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Non-serious TEAEs
Title
Measurements
OG00016
OG0016
STEAEs
Title
Measurements
OG00011
OG0014
AESIs
Title
Measurements
OG0001
OG0011
Participants
OG00014
Title
Denominators
Categories
Non-Serious TEAEs
Title
Measurements
OG00014
STEAEs
Title
Measurements
OG0009
AESIs
Title
Measurements
OG0000
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Non-serious TEAEs
Title
Measurements
OG0005
OG0017
STEAEs
Title
Measurements
OG0003
OG0013
AESIs
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Non-serious TEAEs
Title
Measurements
OG0006
STEAEs
Title
Measurements
OG0003
AESIs
Title
Measurements
OG0000
OG0002
Title
Denominators
Categories
Non-serious TEAEs
Title
Measurements
OG0002
STEAEs
Title
Measurements
OG0002
AESIs
Title
Measurements
OG0000
Participants
OG0001
Title
Denominators
Categories
Non-serious TEAEs
Title
Measurements
OG0001
STEAEs
Title
Measurements
OG0000
AESIs
Title
Measurements
OG0000
OG0000
OG0000
OG0000
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG0010
14
Title
Denominators
Categories
Title
Measurements
OG00042.9
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG00114.3
6
Title
Denominators
Categories
Title
Measurements
OG00050.0
2
Title
Denominators
Categories
Title
Measurements
OG0000
1
Title
Denominators
Categories
Title
Measurements
OG0000
0
0
0
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG0007.59(5.78 to 10.94)
OG001NA(NA to NA)Duration of response could not be calculated as no participants had a confirmed CR or PR in TSR-042 and niraparib 300 mg QD arm.
14
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and full range were not calculable due to more than 50% censored participants in this treatment group.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and full range were not calculable due to more than 50% censored participants in this treatment group.
OG001NA(NA to NA)Median and full range were not calculable due to more than 50% censored participants in this treatment group.
6
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and full range were not calculable due to more than 50% censored participants in this treatment group.
2
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Duration of response could not be calculated as no participants had a confirmed CR or PR.
1
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and full range could not be calculated as there were no confirmed CR or PR.
0
0
0
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG00043.8
OG00133.3
14
Title
Denominators
Categories
Title
Measurements
OG00057.1
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG00083.3
OG00185.7
6
Title
Denominators
Categories
Title
Measurements
OG00083.3
2
Title
Denominators
Categories
Title
Measurements
OG0000
1
Title
Denominators
Categories
Title
Measurements
OG000100
0
0
0
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG0006.2(2.2 to 9.9)
OG0012.8(2.3 to 4.7)
14
Title
Denominators
Categories
Title
Measurements
OG00017.6(3.9 to NA)\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG000NA(8.5 to NA)\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
OG0019.1(8.0 to 11.1)
6
Title
Denominators
Categories
Title
Measurements
OG0007.6(7.4 to NA)\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
2
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and Inter Quartile range could not be estimated due to the low number of participants with events.
1
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and Inter Quartile range could not be estimated due to the low number of participant with event.
0
0
0
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
14
Title
Denominators
Categories
Title
Measurements
OG0004
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
6
Title
Denominators
Categories
Title
Measurements
OG0000
2
Title
Denominators
Categories
Title
Measurements
OG0000
1
Title
Denominators
Categories
Title
Measurements
OG000NAData could not be calculated due to insufficient participant with data.
1
Title
Denominators
Categories
Title
Measurements
OG000NAData could not be calculated due to insufficient participant with data.
0
0
0
0
0
Units
Counts
Participants
OG00015
OG0016
Title
Denominators
Categories
Cycle 1, n=15,6
ParticipantsOG00015
ParticipantsOG0016
Title
Measurements
OG0006.0430± 3.43261
OG0017.8341± 4.76380
Cycle 2, n=10,3
ParticipantsOG00010
ParticipantsOG0013
Title
Measurements
OG00014.9172± 9.82689
OG001
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Cycle 1, n=16,6
ParticipantsOG00016
ParticipantsOG0016
Title
Measurements
OG00026827.7703± 9811.74994
OG00129420.8347± 9262.18751
Cycle 4, n=9,4
ParticipantsOG0009
ParticipantsOG0014
Title
Measurements
OG00055408.3992± 21631.17124
OG001
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG000137108.2574± 41494.15474
OG001
Cycle 11, n=5,0
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000139591.8834± 53844.12650
14
Title
Denominators
Categories
Cycle 1, n=14
ParticipantsOG00014
Title
Measurements
OG00028097.9846± 8440.50578
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG00054730.0053± 15857.69305
Cycle 5, n=9
ParticipantsOG0009
Title
Measurements
OG000124309.5455± 56505.10671
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG000117030.4081± 33852.45635
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Cycle 1, n=6,7
ParticipantsOG0006
ParticipantsOG0017
Title
Measurements
OG0003.4513± 1.23048
OG00111.3601± 5.53524
Cycle 2, n=4,4
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG00014.7473± 8.11715
OG001
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Cycle 1, n=6,7
ParticipantsOG0006
ParticipantsOG0017
Title
Measurements
OG00029830.6542± 8143.36941
OG00126311.1789± 4416.61957
Cycle 4, n=5,7
ParticipantsOG0005
ParticipantsOG0017
Title
Measurements
OG00054268.1379± 14777.09545
OG001
Cycle 5, n=5,6
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000137777.3188± 45794.21973
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG000143070.3093± 74219.00272
OG001
6
Title
Denominators
Categories
Cycle 1, n=6
ParticipantsOG0006
Title
Measurements
OG00032819.5401± 9182.44511
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG00052409.0255± 11814.13244
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG000119847.0999± 27279.85524
Cycle 11, n=4
ParticipantsOG0004
Title
Measurements
OG00077794.6422± 38680.64753
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUC0-t.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUC0-t.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUC0-t.
0
0
0
0
0
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
OG001NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
Units
Counts
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
OG001NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
14
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
OG001NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
OG001NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
6
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThe terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).
0
0
0
0
0
Units
Counts
Participants
OG00015
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000.191953± 0.1309536
OG0010.342333± 0.3301392
Units
Counts
Participants
OG0009
OG0014
Title
Denominators
Categories
Title
Measurements
OG00033.6000± 12.25194
OG00129.8000± 10.32570
9
Title
Denominators
Categories
Title
Measurements
OG00033.9778± 9.89846
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.161233± 0.1072328
OG0010.478714± 0.4197538
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Title
Measurements
OG00037.2750± 16.78102
OG00128.7500± 9.47505
4
Title
Denominators
Categories
Title
Measurements
OG00036.5250± 12.29834
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Ctau.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Ctau.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Ctau.
0
0
0
0
0
Units
Counts
Participants
OG00015
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000.460600± 0.2401100
OG0010.625667± 0.4547692
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG000158.6875± 27.70251
OG001138.9167± 37.87930
14
Title
Denominators
Categories
Title
Measurements
OG000148.2000± 31.27948
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.243667± 0.0889936
OG0010.891571± 0.4638897
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG000138.6667± 24.14677
OG001158.4857± 48.36788
6
Title
Denominators
Categories
Title
Measurements
OG000188.5000± 36.04858
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Cmax.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Cmax.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Cmax.
0
0
0
0
0
Units
Counts
Participants
OG0008
OG0012
Title
Denominators
Categories
Cycle 1, n=1,0
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG00028.5638± NAStandard deviation could not be calculated for single participant.
Cycle 2, n=8,2
ParticipantsOG0008
ParticipantsOG0012
Title
Measurements
OG00016.6295± 8.70836
OG001
Units
Counts
Participants
OG0008
OG0012
Title
Denominators
Categories
Cycle 1, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 4, n=7,2
ParticipantsOG0007
ParticipantsOG0012
Title
Measurements
OG0000.0090± 0.00220
OG0010.0110± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG0000.0081± 0.00238
OG001
Cycle 11, n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0000.0072± 0.00217
10
Title
Denominators
Categories
Cycle 1, n=0
ParticipantsOG0000
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG0000.0098± 0.00292
Cycle 5, n=8
ParticipantsOG0008
Title
Measurements
OG0000.0082± 0.00242
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG0000.0092± 0.00296
Units
Counts
Participants
OG0002
OG0014
Title
Denominators
Categories
Cycle 1, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 2, n=2,4
ParticipantsOG0002
ParticipantsOG0014
Title
Measurements
OG00010.3777± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
OG00114.4947± 8.40967
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Cycle 1, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 4, n=5,5
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0000.0100± 0.00441
OG0010.0104± 0.00268
Cycle 5, n=5,6
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0000.0082± 0.00370
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG0000.0079± 0.00391
OG001
5
Title
Denominators
Categories
Cycle 1, n=0
ParticipantsOG0000
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG0000.0102± 0.00210
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG0000.0087± 0.00169
Cycle 11, n=3
ParticipantsOG0003
Title
Measurements
OG0000.0104± 0.00100
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate CL.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate CL.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate CL.
0
0
0
0
0
Units
Counts
Participants
OG0008
OG0012
Title
Denominators
Categories
Cycle 1, n=1,0
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG000380.1478± NAStandard deviation could not be calculated for single participant.
Cycle 2, n=8,2
ParticipantsOG0008
ParticipantsOG0012
Title
Measurements
OG000716.1418± 554.80278
OG001
Units
Counts
Participants
OG0008
OG0012
Title
Denominators
Categories
Cycle 1, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 4, n=5,2
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0005.6925± 1.46062
OG00110.3984± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG0006.8811± 1.70545
OG001
Cycle 11, n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0007.4795± 0.90952
10
Title
Denominators
Categories
Cycle 1, n=0
ParticipantsOG0000
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG0005.3661± 2.01321
Cycle 5, n=8
ParticipantsOG0008
Title
Measurements
OG0007.2627± 2.43311
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG0008.0529± 3.64454
Units
Counts
Participants
OG0002
OG0012
Title
Denominators
Categories
Cycle 1, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 2, n=2,2
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG000551.4003± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
OG001559.3634± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Cycle 1, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 4, n=5,5
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0006.6462± 2.66825
OG0015.8922± 2.93257
Cycle 5, n=4,6
ParticipantsOG0004
ParticipantsOG0016
Title
Measurements
OG0006.1698± 1.73272
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG0009.6347± 4.05466
OG001
5
Title
Denominators
Categories
Cycle 1, n=0
ParticipantsOG0000
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG0005.4955± 1.89543
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG0006.1542± 1.57345
Cycle 11, n=3
ParticipantsOG0003
Title
Measurements
OG0009.8356± 0.99107
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Vz.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Vz.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Vz.
0
0
0
0
0
Units
Counts
Participants
OG0008
OG0012
Title
Denominators
Categories
Title
Measurements
OG00016.3481± 10.63803
OG00129.4312± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Units
Counts
Participants
OG0008
OG0013
Title
Denominators
Categories
Cycle 4, n=7,2
ParticipantsOG0007
ParticipantsOG0012
Title
Measurements
OG00058598.5076± 15328.61731
OG00146122.3924± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG000135171.2753± 43806.32512
OG001
Cycle 11, n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000151575.3645± 55194.65972
10
Title
Denominators
Categories
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG00055073.0926± 15304.21896
Cycle 5, n=8
ParticipantsOG0008
Title
Measurements
OG000130694.9752± 33923.75772
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG000117033.3612± 33727.51653
Units
Counts
Participants
OG0002
OG0014
Title
Denominators
Categories
Title
Measurements
OG00021.4926± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
OG00126.5006± 14.61077
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Cycle 4, n=5,5
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG00055974.4268± 16738.05254
OG00150924.1510± 13339.28085
Cycle 5, n=5,6
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000137399.5881± 45511.62023
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG000147907.5379± 60795.87607
OG001
5
Title
Denominators
Categories
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG00051140.4410± 12597.07380
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG000118845.3928± 27874.98871
Cycle 11, n=3
ParticipantsOG0003
Title
Measurements
OG00096800.1534± 8871.32089
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUCss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUCss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate AUCss.
0
0
0
0
0
Units
Counts
Participants
OG00011
OG0016
Title
Denominators
Categories
Cycle 2, n=11,6
ParticipantsOG00011
ParticipantsOG0016
Title
Measurements
OG0000.507900± 0.3937657
OG0010.622000± 0.4523848
Cycle 5, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 11, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Cycle 4, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG00077.3625± 28.55145
OG00163.3000± NAStandard deviation could not be calculated for single participant.
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG00068.5500± 34.63879
OG001
Cycle 11, n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00093.8000± 47.28939
9
Title
Denominators
Categories
Cycle 4, n=9
ParticipantsOG0009
Title
Measurements
OG00067.2444± 24.15130
Cycle 5, n=8
ParticipantsOG0008
Title
Measurements
OG00059.3000± 16.75913
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG00057.4833± 20.98136
Units
Counts
Participants
OG0005
OG0014
Title
Denominators
Categories
Cycle 2, n=5,4
ParticipantsOG0005
ParticipantsOG0014
Title
Measurements
OG0000.484000± 0.3511339
OG0011.094250± 0.7660576
Cycle 5, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 11, n=0,0
ParticipantsOG0000
ParticipantsOG0010
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Cycle 4, n=4,6
ParticipantsOG0004
ParticipantsOG0016
Title
Measurements
OG00070.4250± 34.00896
OG00164.2667± 23.55315
Cycle 5, n=5,6
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG00082.9800± 43.98252
OG001
Cycle 11, n=3,2
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG000105.4667± 22.28909
OG001
5
Title
Denominators
Categories
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG00053.5200± 13.87271
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG00048.0800± 23.95343
Cycle 11, n=3
ParticipantsOG0003
Title
Measurements
OG00043.3000± 4.80729
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Ctau,ss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Ctau,ss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Ctau,ss.
0
0
0
0
0
Units
Counts
Participants
OG00010
OG0013
Title
Denominators
Categories
Cycle 2, n=10,3
ParticipantsOG00010
ParticipantsOG0013
Title
Measurements
OG0000.925900± 0.6661597
OG0011.706667± 0.0838650
Cycle 5, n=7,0
ParticipantsOG0007
ParticipantsOG0010
Title
Measurements
OG0000.839071± 0.6183628
Cycle 11, n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG0000.768000± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Units
Counts
Participants
OG0009
OG0014
Title
Denominators
Categories
Cycle 4, n=9,4
ParticipantsOG0009
ParticipantsOG0014
Title
Measurements
OG000222.5556± 51.37633
OG001178.5000± 26.18524
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG000393.8750± 100.81729
OG001
Cycle 11, n=5,0
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000405.4000± 103.69812
10
Title
Denominators
Categories
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG000225.8000± 51.71460
Cycle 5, n=9
ParticipantsOG0009
Title
Measurements
OG000421.1111± 114.84603
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG000446.6667± 160.53868
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Cycle 2, n=4,4
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG0000.854500± 0.3934637
OG0011.404750± 0.6642366
Cycle 5, n=4,3
ParticipantsOG0004
ParticipantsOG0013
Title
Measurements
OG0000.709750± 0.2693788
OG001
Cycle 11, n=3,1
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000.468333± 0.1418955
OG001
Units
Counts
Participants
OG0005
OG0017
Title
Denominators
Categories
Cycle 4, n=5,7
ParticipantsOG0005
ParticipantsOG0017
Title
Measurements
OG000234.4000± 31.76948
OG001227.1429± 42.65923
Cycle 5, n=5,6
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000325.2000± 73.90332
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG000349.7500± 111.53886
OG001
5
Title
Denominators
Categories
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG000256.8000± 76.90709
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG000416.0000± 89.43433
Cycle 11, n=4
ParticipantsOG0004
Title
Measurements
OG000429.7500± 72.86231
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Cmax,ss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Cmax,ss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Cmax,ss.
0
0
0
0
0
Units
Counts
Participants
OG00015
OG0016
Title
Denominators
Categories
Title
Measurements
OG0002.250(1.75 to 7.02)
OG0014.083(2.02 to 25.65)
Participants
OG00016
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000.817(0.50 to 2.58)
OG0011.750(0.50 to 23.17)
14
Title
Denominators
Categories
Title
Measurements
OG0001.000(0.55 to 27.28)
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0003.975(2.00 to 23.33)
OG0014.050(2.05 to 22.60)
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0001.200(0.50 to 4.48)
OG0010.583(0.50 to 2.35)
6
Title
Denominators
Categories
Title
Measurements
OG0001.250(0.50 to 25.17)
2
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not collected due to insufficient number of participants with data to calculate Tmax.
1
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not collected due to insufficient number of participants with data to calculate Tmax.
1
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not collected due to insufficient number of participants with data to calculate Tmax.
0
0
0
0
0
Units
Counts
Participants
OG00010
OG0013
Title
Denominators
Categories
Cycle 2, n=10,3
ParticipantsOG00010
ParticipantsOG0013
Title
Measurements
OG0004.008(1.00 to 22.68)
OG0012.250(2.08 to 7.00)
Cycle 5, n=7,0
ParticipantsOG0007
ParticipantsOG0010
Title
Measurements
OG0002.000(0.00 to 2.00)
Cycle 11, n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG0001.817(1.75 to 1.88)
Units
Counts
Participants
OG0009
OG0014
Title
Denominators
Categories
Cycle 4, n=9,4
ParticipantsOG0009
ParticipantsOG0014
Title
Measurements
OG0001.500(0.50 to 2.07)
OG0011.300(0.50 to 2.70)
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG0000.625(0.50 to 1.73)
OG001
Cycle 11, n=5,0
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG0000.567(0.50 to 2.00)
10
Title
Denominators
Categories
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG0000.575(0.50 to 2.08)
Cycle 5, n=9
ParticipantsOG0009
Title
Measurements
OG0001.500(0.50 to 2.10)
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG0000.542(0.42 to 2.07)
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Cycle 2, n=4,4
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG0004.950(2.03 to 22.30)
OG0013.958(2.00 to 6.00)
Cycle 5, n=4,3
ParticipantsOG0004
ParticipantsOG0013
Title
Measurements
OG0002.158(1.82 to 2.68)
OG001
Cycle 11, n=3,1
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0002.000(0.00 to 2.00)
OG001
Units
Counts
Participants
OG0005
OG0017
Title
Denominators
Categories
Cycle 4, n=5,7
ParticipantsOG0005
ParticipantsOG0017
Title
Measurements
OG0001.517(0.50 to 20.67)
OG0010.617(0.50 to 2.00)
Cycle 5, n=5,6
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0002.083(0.50 to 2.58)
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG0002.000(1.98 to 2.00)
OG001
5
Title
Denominators
Categories
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG0000.500(0.50 to 2.00)
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG0000.550(0.50 to 2.00)
Cycle 11, n=4
ParticipantsOG0004
Title
Measurements
OG0000.500(0.50 to 0.50)
2
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.
0
0
0
0
0
Units
Counts
Participants
OG0008
OG0012
Title
Denominators
Categories
Cycle 4, n=5,2
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0005.5647± 1.36694
OG0019.8680± NAStandard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
Cycle 5, n=8,1
ParticipantsOG0008
ParticipantsOG0011
Title
Measurements
OG0006.6580± 1.53521
OG001
Cycle 11, n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0007.3107± 0.96007
10
Title
Denominators
Categories
Cycle 4, n=10
ParticipantsOG00010
Title
Measurements
OG0005.1893± 1.80311
Cycle 5, n=8
ParticipantsOG0008
Title
Measurements
OG0006.7701± 2.31992
Cycle 11, n=6
ParticipantsOG0006
Title
Measurements
OG0007.4351± 2.78481
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Cycle 4, n=5,5
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0006.4567± 2.68944
OG0015.5177± 2.39652
Cycle 5, n=4,6
ParticipantsOG0004
ParticipantsOG0016
Title
Measurements
OG0006.2405± 1.79539
OG001
Cycle 11, n=4,2
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG0008.9478± 3.05769
OG001
5
Title
Denominators
Categories
Cycle 4, n=5
ParticipantsOG0005
Title
Measurements
OG0005.1493± 1.58340
Cycle 5, n=5
ParticipantsOG0005
Title
Measurements
OG0005.6399± 1.41478
Cycle 11, n=3
ParticipantsOG0003
Title
Measurements
OG0008.0614± 0.48037
2
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Vss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Vss.
1
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData was not collected due to insufficient number of participants with data to calculate Vss.
0
0
0
0
0
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
3 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0091 events1 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG00515 events4 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
3 events
2 affected
6 at risk
EG0045 events2 affected7 at risk
EG00519 events2 affected6 at risk
EG0060 events0 affected2 at risk
EG0072 events1 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0054 events3 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
4 events
4 affected
6 at risk
EG0044 events4 affected7 at risk
EG0056 events3 affected6 at risk
EG0062 events2 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
2 events
2 affected
6 at risk
EG0044 events4 affected7 at risk
EG00521 events4 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
4 events
3 affected
6 at risk
EG0046 events4 affected7 at risk
EG0059 events3 affected6 at risk
EG0064 events2 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
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6 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected6 at risk
EG0062 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0062 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
5 events
4 affected
6 at risk
EG0041 events1 affected7 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
2 events
2 affected
6 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0049 events4 affected7 at risk
EG0057 events3 affected6 at risk
EG0062 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0042 events2 affected7 at risk
EG0053 events2 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
2 events
2 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
2 events
2 affected
6 at risk
EG0043 events2 affected7 at risk
EG0057 events3 affected6 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
2 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0056 events5 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected7 at risk
EG0054 events2 affected6 at risk
EG0060 events0 affected2 at risk
EG0072 events1 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
4 events
4 affected
6 at risk
EG0042 events2 affected7 at risk
EG0055 events3 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0053 events2 affected6 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected1 at risk
29.3024
± 2.15129
29311.8182
± 16546.73177
141328.9288
± NA
Standard deviation could not be calculated for single participant.
24.9691
± 17.50367
49198.8237
± 12507.66126
131281.9046
± 36835.39730
119161.8795
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
10.2833
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
0.0071
± NA
Standard deviation could not be calculated for single participant.
0.0082
± 0.00273
0.0086
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
487.8826
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
6.3070
± NA
Standard deviation could not be calculated for single participant.
5.2066
± 1.07206
8.5098
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
141306.3782
± NA
Standard deviation could not be calculated for single participant.
131288.0291
± 36816.18787
119189.5905
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
71.2000
± NA
Standard deviation could not be calculated for single participant.
53.1500
± 24.80538
60.9500
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
319.0000
± NA
Standard deviation could not be calculated for single participant.
1.073667
± 0.5474124
0.638000
± NA
Standard deviation could not be calculated for single participant.
417.3333
± 139.40397
321.0000
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
2.783
(NA to NA)
Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.
1.967
(1.17 to 2.00)
2.083
(NA to NA)
Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.
0.825
(0.50 to 2.25)
2.417
(2.17 to 2.67)
5.9659
± NA
Standard deviation could not be calculated for single participant.
4.8035
± 0.72905
7.7750
± NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.