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Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Sponsor
Tesaro, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03307785
Collaborator
(none)
58
Enrollment
8
Locations
11
Arms
54.5
Anticipated Duration (Months)
7.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 12, 2017
Actual Primary Completion Date :
Feb 26, 2020
Anticipated Study Completion Date :
Apr 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: TSR-042 and niraparib 200 mg QD

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
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.
Other Names:
  • Zejula

    • Drug: TSR-042
    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).
    Experimental: Part A: TSR-042 and niraparib 300 mg QD

    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
    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.
    Other Names:
  • Zejula

    • Drug: TSR-042
    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).
    Experimental: Part B: TSR-042 and carboplatin-paclitaxel

    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
    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).

    Drug: Carboplatin-Paclitaxel
    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.
    Experimental: Part C: TSR-042, niraparib 200 mg QD and bevacizumab

    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.

    Drug: Niraparib
    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.
    Other Names:
  • Zejula

    • Drug: TSR-042
    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).

    Drug: Bevacizumab
    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.
    Other Names:
  • Avastin

    		•
    Experimental: Part C: TSR-042, niraparib 300 mg QD and bevacizumab

    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
    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.
    Other Names:
  • Zejula

    • Drug: TSR-042
    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).

    Drug: Bevacizumab
    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.
    Other Names:
  • Avastin

    		•
    Experimental: Part D: TSR-042, carboplatin-paclitaxel and bevacizumab

    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
    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).

    Drug: Carboplatin-Paclitaxel
    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.

    Drug: Bevacizumab
    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.
    Other Names:
  • Avastin

    		•
    Experimental: Part E: TSR-042 and carboplatin-pemetrexed

    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
    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).

    Drug: Carboplatin-Pemetrexed
    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
    Experimental: Part F: TSR-042, TSR-022, and carboplatin-pemetrexed

    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
    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).

    Drug: TSR-022
    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.

    Drug: Carboplatin-Pemetrexed
    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
    Experimental: Part G: TSR-042 and carboplatin-nab-paclitaxel

    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
    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).

    Drug: Carboplatin-Nab-Paclitaxel
    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.
    Experimental: Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel

    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
    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).

    Drug: TSR-022
    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.

    Drug: Carboplatin-Nab-Paclitaxel
    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.
    Experimental: Part I: TSR-042, TSR-022, and carboplatin-paclitaxel

    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
    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).

    Drug: Carboplatin-Paclitaxel
    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.

    Drug: TSR-022
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Part A: Number of Participants With Dose-limiting Toxicity (DLT) [21 days]

      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).

    2. Part B: Number of Participants With DLT [21 days]

      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.

    3. Part C: Number of Participants With DLT [21 days]

      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.

    4. Part D: Number of Participants With DLT [21 days]

      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.

    5. Part E: Number of Participants With DLT [21 days]

      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.

    6. Part F: Number of Participants With DLT [21 days]

      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.

    7. Part G: Number of Participants With DLT [21 days]

      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.

    8. Part H: Number of Participants With DLT [21 days]

      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.

    9. Part I: Number of Participants With DLT [21 days]

      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.

    10. Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs) [Up to 28.5 months]

      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.

    11. Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 28.5 months]

      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.

    12. Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 22.5 months]

      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.

    13. Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 9.5 months]

      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.

    14. Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 4.4 months]

      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.

    15. Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 3.5 months]

      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.

    16. Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 24 months]

      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.

    17. Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 24 months]

      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.

    18. Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs [Up to 24 months]

      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.

    Secondary Outcome Measures

    1. Part A: Objective Response Rate [Up to 28.5 months]

      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.

    2. Part B: Objective Response Rate [Up to 28.5 months]

      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.

    3. Part C: Objective Response Rate [Up to 22.5 months]

      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.

    4. Part D: Objective Response Rate [Up to 9.5 months]

      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.

    5. Part E: Objective Response Rate [Up to 4.4 months]

      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.

    6. Part F: Objective Response Rate [Up to 3.5 months]

      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.

    7. Part G: Objective Response Rate [Up to 24 months]

      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.

    8. Part H: Objective Response Rate [Up to 24 months]

      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.

    9. Part I: Objective Response Rate [Up to 24 months]

      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.

    10. Part A: Duration of Response [Up to 28.5 months]

      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.

    11. Part B: Duration of Response [Up to 28.5 months]

      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. Data is not reported as participants response is still ongoing at the time of primary analysis.

    12. Part C: Duration of Response [Up to 22.5 months]

      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. Data is not reported as participants response is still ongoing at the time of primary analysis.

    13. Part D: Duration of Response [Up to 9.5 months]

      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. Data is not reported as participants response is still ongoing at the time of primary analysis.

    14. Part E: Duration of Response [Up to 4.4 months]

      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.

    15. Part F: Duration of Response [Up to 3.5 months]

      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.

    16. Part G: Duration of Response [Up to 24 months]

      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.

    17. Part H: Duration of Response [Up to 24 months]

      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.

    18. Part I: Duration of Response [Up to 24 months]

      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.

    19. Part A: Disease Control Rate [Up to 28.5 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.

    20. Part B: Disease Control Rate [Up to 28.5 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    21. Part C: Disease Control Rate [Up to 22.5 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    22. Part D: Disease Control Rate [Up to 9.5 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    23. Part E: Disease Control Rate [Up to 4.4 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    24. Part F: Disease Control Rate [Up to 3.5 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    25. Part G: Disease Control Rate [Up to 24 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    26. Part H: Disease Control Rate [Up to 24 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    27. Part I: Disease Control Rate [Up to 24 months]

      Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

    28. Part A: Progression-free Survival [Up to 28.5 months]

      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.

    29. Part B: Progression-free Survival [Up to 28.5 months]

      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.

    30. Part C: Progression-free Survival [Up to 22.5 months]

      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.

    31. Part D: Progression-free Survival [Up to 9.5 months]

      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.

    32. Part E: Progression-free Survival [Up to 4.4 months]

      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.

    33. Part F: Progression-free Survival [Up to 3.5 months]

      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.

    34. Part G: Progression-free Survival [Up to 24 months]

      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.

    35. Part H: Progression-free Survival [Up to 24 months]

      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.

    36. Part I: Progression-free Survival [Up to 24 months]

      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.

    37. Part A: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 28.5 months]

      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.

    38. Part B: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 28.5 months]

      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).

    39. Part C: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 22.5 months]

      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).

    40. Part D: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 9.5 months]

      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).

    41. Part E: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 4.4 months]

      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).

    42. Part F: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 3.5 months]

      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).

    43. Part F: Number of Participants With Positive Anti-TSR-022 Antibodies [Up to 3.5 months]

      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).

    44. Part G: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 24 months]

      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).

    45. Part H: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 24 months]

      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).

    46. Part H: Number of Participants With Positive Anti-TSR-022 Antibodies [Up to 24 months]

      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).

    47. Part I: Number of Participants With Positive Anti-TSR-042 Antibodies [Up to 24 months]

      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).

    48. Part I: Number of Participants With Positive Anti-TSR-022 Antibodies [Up to 24 months]

      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).

    49. Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      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.

    50. Part A: AUC(0-t) of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    51. Part B: AUC0-t of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    52. Part C: AUC0-t of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    53. Part C: AUC0-t of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    54. Part D: AUC0-t of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    55. Part E: AUC0-t of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    56. Part F: AUC0-t of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    57. Part F: AUC0-t of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    58. Part G: AUC0-t of TSR-042 [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)]

      Blood samples were planned to be collected at indicated time points.

    59. Part H: AUC0-t of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    60. Part H: AUC0-t of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    61. Part I: AUC0-t of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    62. Part I: AUC0-t of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    63. Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    64. Part A: AUC(0-infinity) of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    65. Part B: AUC(0-infinity) of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    66. Part C: AUC(0-infinity) of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    67. Part C: AUC(0-infinity) of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    68. Part D: AUC(0-infinity) of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    69. Part E: AUC(0-infinity) of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    70. Part F: AUC(0-infinity) of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    71. Part F: AUC(0-infinity) of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    72. Part G: AUC(0-infinity) of TSR-042 [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)]

      Blood samples were planned to be collected at indicated time points.

    73. Part H: AUC(0-infinity) of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    74. Part H: AUC(0-infinity) of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    75. Part I: AUC(0-infinity) of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    76. Part I: AUC(0-infinity) of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    77. Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib [Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    78. Part A: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    79. Part B: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    80. Part C: Ctau of Niraparib [Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    81. Part C: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    82. Part D: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    83. Part E: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    84. Part F: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    85. Part F: Ctau of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    86. Part G: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    87. Part H: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    88. Part H: Ctau of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    89. Part I: Ctau of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    90. Part I: Ctau of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    91. Part A: Maximum Observed Plasma (Cmax) of Niraparib [Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    92. Part A: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    93. Part B: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    94. Part C: Cmax of Niraparib [Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    95. Part C: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    96. Part D: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    97. Part E: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    98. Part F: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    99. Part F: Cmax of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    100. Part G: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    101. Part H: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    102. Part H: Cmax of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    103. Part I: Cmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    104. Part I: Cmax of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    105. Part A: Clearance After Oral Administration (CL/F) of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    106. Part A: Clearance After Intravenous Administration (CL) of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    107. Part B: CL of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    108. Part C: CL/F of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    109. Part C: CL of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    110. Part D: CL of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    111. Part E: CL of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    112. Part F: CL of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    113. Part F: CL of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    114. Part G: CL of TSR-042 [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)]

      Blood samples were planned to be collected at indicated time points.

    115. Part H: CL of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    116. Part H: CL of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    117. Part I: CL of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    118. Part I: CL of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    119. Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    120. Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    121. Part B: Vz of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    122. Part C: Vz/F of Niraparib [Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    123. Part C: Vz of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    124. Part D: Vz of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    125. Part E: Vz of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    126. Part F: Vz of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    127. Part F: Vz of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    128. Part G: Vz of TSR-042 [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)]

      Blood samples were planned to be collected at indicated time points.

    129. Part H: Vz of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    130. Part H: Vz of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    131. Part I: Vz of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    132. Part I: Vz of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    133. Part A: AUC at Steady State (AUCss) of Niraparib [Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    134. Part A: AUCss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    135. Part B: AUCss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    136. Part C: AUCss of Niraparib [Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    137. Part C: AUCss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    138. Part D: AUCss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    139. Part E: AUCss of TSR-042 [Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    140. Part F: AUCss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    141. Part F: AUCss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    142. Part G: AUCss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    143. Part H: AUCss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    144. Part H: AUCss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    145. Part I: AUCss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    146. Part I: AUCss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    147. Part A: Ctau at Steady State (Ctau,ss) of Niraparib [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)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    148. Part A: Ctau,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    149. Part B: Ctau,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    150. Part C: Ctau,ss of Niraparib [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)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    151. Part C: Ctau,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    152. Part D: Ctau,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    153. Part E: Ctau,ss of TSR-042 [Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    154. Part F: Ctau,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    155. Part F: Ctau,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    156. Part G: Ctau,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    157. Part H: Ctau,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    158. Part H: Ctau,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    159. Part I: Ctau,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    160. Part I: Ctau,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    161. Part A: Cmax at Steady State (Cmax,ss) of Niraparib [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)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    162. Part A: Cmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    163. Part B: Cmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    164. Part C: Cmax,ss of Niraparib [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)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    165. Part C: Cmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    166. Part D: Cmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    167. Part E: Cmax,ss of TSR-042 [Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    168. Part F: Cmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    169. Part F: Cmax,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    170. Part G: Cmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    171. Part H: Cmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    172. Part H: Cmax,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    173. Part I: Cmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    174. Part I: Cmax,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    175. Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib [Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    176. Part A: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    177. Part B: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    178. Part C: Tmax of Niraparib [Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    179. Part C: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    180. Part D: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    181. Part E: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    182. Part F: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    183. Part F: Tmax of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    184. Part G: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    185. Part H: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    186. Part H: Tmax of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    187. Part I: Tmax of TSR-042 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    188. Part I: Tmax of TSR-022 [Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    189. Part A: Tmax at Steady State (Tmax,ss) of Niraparib [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)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    190. Part A: Tmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    191. Part B: Tmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    192. Part C: Tmax,ss of Niraparib [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)]

      Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

    193. Part C: Tmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    194. Part D: Tmax,ss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    195. Part E: Tmax,ss of TSR-042 [Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    196. Part F: Tmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    197. Part F: Tmax,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    198. Part G: Tmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    199. Part H: Tmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    200. Part H: Tmax,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    201. Part I: Tmax,ss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    202. Part I: Tmax,ss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    203. Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    204. Part B: Vss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    205. Part C: Vss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    206. Part D: Vss of TSR-042 [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)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    207. Part E: Vss of TSR-042 [Cycle 2: Pre-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    208. Part F: Vss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

    209. Part F: Vss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

    210. Part G: Vss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    211. Part H: Vss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    212. Part H: Vss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    213. Part I: Vss of TSR-042 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    214. Part I: Vss of TSR-022 [Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)]

      Blood samples were planned to be collected at indicated time points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Scottsdale Arizona United States 85258
    2 GSK Investigational Site Encinitas California United States 92024
    3 GSK Investigational Site San Marcos California United States 92069
    4 GSK Investigational Site Sarasota Florida United States 34232
    5 GSK Investigational Site Canton Ohio United States 44718
    6 GSK Investigational Site Cleveland Ohio United States 44106
    7 GSK Investigational Site Nashville Tennessee United States 37203
    8 GSK Investigational Site Houston Texas United States 77030

    Sponsors and Collaborators

    • Tesaro, Inc.

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Tesaro, Inc.
    ClinicalTrials.gov Identifier:
    NCT03307785
    Other Study ID Numbers:
    • 213351
    • 3000-01-002
    First Posted:
    Oct 12, 2017
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Neoplasm Metastasis
    Paclitaxel
    Albumin-Bound Paclitaxel
    Bevacizumab
    Carboplatin
    Pemetrexed
    Niraparib

    Study Results

    Participant Flow

    Recruitment Details This was a multicenter, open-label study conducted in participants with advanced or metastatic cancer. The results presented are based on primary analysis up to maximum 28.5 months. Data collection is still on-going and additional results will be provided after study completion.
    Pre-assignment Detail A total of 58 participants were enrolled in the study. This 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.
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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). 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). 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. 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. 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).
    Period Title: Part A: Up to 28.5 Months
    STARTED 16 6 0 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 16 6 0 0 0 0 0 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 14 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 14 0 0 0 0 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 6 7 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 6 7 0 0 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 0 0 6 0 0 0 0 0
    COMPLETED 0 0 0 0 0 3 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 3 0 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 0 0 0 2 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 2 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 0 0 0 0 1 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 1 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    Period Title: Part A: Up to 28.5 Months
    STARTED 0 0 0 0 0 0 0 0 0 0 0
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title 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 Total
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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). 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). 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. 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. 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). Total of all reporting groups
    Overall Participants 16 6 14 6 7 6 2 1 0 0 0 58
    Age, Customized (Count of Participants)
    18-64 years
    8
    50%
    3
    50%
    5
    35.7%
    4
    66.7%
    6
    85.7%
    2
    33.3%
    1
    50%
    1
    100%
    0
    NaN
    0
    NaN
    0
    NaN
    30
    51.7%
    65-74 years
    6
    37.5%
    1
    16.7%
    4
    28.6%
    2
    33.3%
    1
    14.3%
    3
    50%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    17
    29.3%
    >=75 years
    2
    12.5%
    2
    33.3%
    5
    35.7%
    0
    0%
    0
    0%
    1
    16.7%
    1
    50%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    11
    19%
    Sex: Female, Male (Count of Participants)
    Female
    9
    56.3%
    2
    33.3%
    8
    57.1%
    4
    66.7%
    7
    100%
    5
    83.3%
    0
    0%
    NA
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    NA
    NaN
    Male
    7
    43.8%
    4
    66.7%
    6
    42.9%
    2
    33.3%
    0
    0%
    1
    16.7%
    2
    100%
    NA
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    NA
    NaN
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    0
    0%
    1
    16.7%
    1
    7.1%
    0
    0%
    2
    28.6%
    0
    0%
    1
    50%
    NA
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    NA
    NaN
    White
    16
    100%
    5
    83.3%
    13
    92.9%
    6
    100%
    5
    71.4%
    6
    100%
    1
    50%
    NA
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    NA
    NaN

    Outcome Measures

    1. Primary Outcome
    Title Part A: Number of Participants With Dose-limiting Toxicity (DLT)
    Description 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).
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population consisted of all participants who received any amount of study treatment.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Count of Participants [Participants]
    2
    12.5%
    0
    0%
    2. Primary Outcome
    Title Part B: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Count of Participants [Participants]
    1
    6.3%
    3. Primary Outcome
    Title Part C: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Count of Participants [Participants]
    1
    6.3%
    1
    16.7%
    4. Primary Outcome
    Title Part D: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Count of Participants [Participants]
    0
    0%
    5. Primary Outcome
    Title Part E: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Count of Participants [Participants]
    0
    0%
    6. Primary Outcome
    Title Part F: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Count of Participants [Participants]
    0
    0%
    7. Primary Outcome
    Title Part G: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    8. Primary Outcome
    Title Part H: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    9. Primary Outcome
    Title Part I: Number of Participants With DLT
    Description 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.
    Time Frame 21 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    10. Primary Outcome
    Title Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Non-serious TEAEs
    16
    100%
    6
    100%
    STEAEs
    11
    68.8%
    4
    66.7%
    AESIs
    1
    6.3%
    1
    16.7%
    11. Primary Outcome
    Title Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Non-Serious TEAEs
    14
    87.5%
    STEAEs
    9
    56.3%
    AESIs
    0
    0%
    12. Primary Outcome
    Title Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 22.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Non-serious TEAEs
    5
    31.3%
    7
    116.7%
    STEAEs
    3
    18.8%
    3
    50%
    AESIs
    0
    0%
    0
    0%
    13. Primary Outcome
    Title Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 9.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Non-serious TEAEs
    6
    37.5%
    STEAEs
    3
    18.8%
    AESIs
    0
    0%
    14. Primary Outcome
    Title Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 4.4 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Non-serious TEAEs
    2
    12.5%
    STEAEs
    2
    12.5%
    AESIs
    0
    0%
    15. Primary Outcome
    Title Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Non-serious TEAEs
    1
    6.3%
    STEAEs
    0
    0%
    AESIs
    0
    0%
    16. Primary Outcome
    Title Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    17. Primary Outcome
    Title Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    18. Primary Outcome
    Title Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    19. Secondary Outcome
    Title Part A: Objective Response Rate
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Number [Percentage of participants]
    25.0
    156.3%
    0
    0%
    20. Secondary Outcome
    Title Part B: Objective Response Rate
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Number [Percentage of participants]
    42.9
    268.1%
    21. Secondary Outcome
    Title Part C: Objective Response Rate
    Description 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.
    Time Frame Up to 22.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Number [Percentage of participants]
    50.0
    312.5%
    14.3
    238.3%
    22. Secondary Outcome
    Title Part D: Objective Response Rate
    Description 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.
    Time Frame Up to 9.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Number [Percentage of participants]
    50.0
    312.5%
    23. Secondary Outcome
    Title Part E: Objective Response Rate
    Description 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.
    Time Frame Up to 4.4 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Number [Percentage of participants]
    0
    0%
    24. Secondary Outcome
    Title Part F: Objective Response Rate
    Description 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.
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Number [Percentage of participants]
    0
    0%
    25. Secondary Outcome
    Title Part G: Objective Response Rate
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    26. Secondary Outcome
    Title Part H: Objective Response Rate
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    27. Secondary Outcome
    Title Part I: Objective Response Rate
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    28. Secondary Outcome
    Title Part A: Duration of Response
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Median (Full Range) [Months]
    7.59
    NA
    29. Secondary Outcome
    Title Part B: Duration of Response
    Description 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. Data is not reported as participants response is still ongoing at the time of primary analysis.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    30. Secondary Outcome
    Title Part C: Duration of Response
    Description 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. Data is not reported as participants response is still ongoing at the time of primary analysis.
    Time Frame Up to 22.5 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    31. Secondary Outcome
    Title Part D: Duration of Response
    Description 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. Data is not reported as participants response is still ongoing at the time of primary analysis.
    Time Frame Up to 9.5 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    32. Secondary Outcome
    Title Part E: Duration of Response
    Description 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.
    Time Frame Up to 4.4 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Median (Full Range) [Months]
    NA
    33. Secondary Outcome
    Title Part F: Duration of Response
    Description 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.
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Median (Full Range) [Months]
    NA
    34. Secondary Outcome
    Title Part G: Duration of Response
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    35. Secondary Outcome
    Title Part H: Duration of Response
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    36. Secondary Outcome
    Title Part I: Duration of Response
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    37. Secondary Outcome
    Title Part A: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Number [Percentage of participants]
    43.8
    273.8%
    33.3
    555%
    38. Secondary Outcome
    Title Part B: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Number [Percentage of participants]
    57.1
    356.9%
    39. Secondary Outcome
    Title Part C: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 22.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Number [Percentage of participants]
    83.3
    520.6%
    85.7
    1428.3%
    40. Secondary Outcome
    Title Part D: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 9.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Number [Percentage of participants]
    83.3
    520.6%
    41. Secondary Outcome
    Title Part E: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 4.4 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Number [Percentage of participants]
    0
    0%
    42. Secondary Outcome
    Title Part F: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Number [Percentage of participants]
    100
    625%
    43. Secondary Outcome
    Title Part G: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    44. Secondary Outcome
    Title Part H: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    45. Secondary Outcome
    Title Part I: Disease Control Rate
    Description Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    46. Secondary Outcome
    Title Part A: Progression-free Survival
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Median (Inter-Quartile Range) [Months]
    6.2
    2.8
    47. Secondary Outcome
    Title Part B: Progression-free Survival
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Median (Inter-Quartile Range) [Months]
    17.6
    48. Secondary Outcome
    Title Part C: Progression-free Survival
    Description 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.
    Time Frame Up to 22.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Median (Inter-Quartile Range) [Months]
    NA
    9.1
    49. Secondary Outcome
    Title Part D: Progression-free Survival
    Description 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.
    Time Frame Up to 9.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Median (Inter-Quartile Range) [Months]
    7.6
    50. Secondary Outcome
    Title Part E: Progression-free Survival
    Description 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.
    Time Frame Up to 4.4 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Median (Inter-Quartile Range) [Months]
    NA
    51. Secondary Outcome
    Title Part F: Progression-free Survival
    Description 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.
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Median (Inter-Quartile Range) [Months]
    NA
    52. Secondary Outcome
    Title Part G: Progression-free Survival
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    53. Secondary Outcome
    Title Part H: Progression-free Survival
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    54. Secondary Outcome
    Title Part I: Progression-free Survival
    Description 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.
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    55. Secondary Outcome
    Title Part A: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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.
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Count of Participants [Participants]
    0
    0%
    0
    0%
    56. Secondary Outcome
    Title Part B: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 28.5 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Count of Participants [Participants]
    4
    25%
    57. Secondary Outcome
    Title Part C: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 22.5 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Count of Participants [Participants]
    0
    0%
    0
    0%
    58. Secondary Outcome
    Title Part D: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 9.5 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Count of Participants [Participants]
    0
    0%
    59. Secondary Outcome
    Title Part E: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 4.4 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Count of Participants [Participants]
    0
    0%
    60. Secondary Outcome
    Title Part F: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Count of Participants [Participants]
    NA
    NaN
    61. Secondary Outcome
    Title Part F: Number of Participants With Positive Anti-TSR-022 Antibodies
    Description 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).
    Time Frame Up to 3.5 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Count of Participants [Participants]
    NA
    NaN
    62. Secondary Outcome
    Title Part G: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    63. Secondary Outcome
    Title Part H: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    64. Secondary Outcome
    Title Part H: Number of Participants With Positive Anti-TSR-022 Antibodies
    Description 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).
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    65. Secondary Outcome
    Title Part I: Number of Participants With Positive Anti-TSR-042 Antibodies
    Description 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).
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    66. Secondary Outcome
    Title Part I: Number of Participants With Positive Anti-TSR-022 Antibodies
    Description 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).
    Time Frame Up to 24 months

    Outcome Measure Data

    Analysis Population Description
    Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    67. Secondary Outcome
    Title Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
    Description 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.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 15 6
    Cycle 1, n=15,6
    6.0430
    (3.43261)
    7.8341
    (4.76380)
    Cycle 2, n=10,3
    14.9172
    (9.82689)
    29.3024
    (2.15129)
    68. Secondary Outcome
    Title Part A: AUC(0-t) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Cycle 1, n=16,6
    26827.7703
    (9811.74994)
    29420.8347
    (9262.18751)
    Cycle 4, n=9,4
    55408.3992
    (21631.17124)
    29311.8182
    (16546.73177)
    Cycle 5, n=8,1
    137108.2574
    (41494.15474)
    141328.9288
    (NA)
    Cycle 11, n=5,0
    139591.8834
    (53844.12650)
    69. Secondary Outcome
    Title Part B: AUC0-t of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Cycle 1, n=14
    28097.9846
    (8440.50578)
    Cycle 4, n=10
    54730.0053
    (15857.69305)
    Cycle 5, n=9
    124309.5455
    (56505.10671)
    Cycle 11, n=6
    117030.4081
    (33852.45635)
    70. Secondary Outcome
    Title Part C: AUC0-t of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Cycle 1, n=6,7
    3.4513
    (1.23048)
    11.3601
    (5.53524)
    Cycle 2, n=4,4
    14.7473
    (8.11715)
    24.9691
    (17.50367)
    71. Secondary Outcome
    Title Part C: AUC0-t of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Cycle 1, n=6,7
    29830.6542
    (8143.36941)
    26311.1789
    (4416.61957)
    Cycle 4, n=5,7
    54268.1379
    (14777.09545)
    49198.8237
    (12507.66126)
    Cycle 5, n=5,6
    137777.3188
    (45794.21973)
    131281.9046
    (36835.39730)
    Cycle 11, n=4,2
    143070.3093
    (74219.00272)
    119161.8795
    (NA)
    72. Secondary Outcome
    Title Part D: AUC0-t of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Cycle 1, n=6
    32819.5401
    (9182.44511)
    Cycle 4, n=5
    52409.0255
    (11814.13244)
    Cycle 5, n=5
    119847.0999
    (27279.85524)
    Cycle 11, n=4
    77794.6422
    (38680.64753)
    73. Secondary Outcome
    Title Part E: AUC0-t of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    NA
    (NA)
    74. Secondary Outcome
    Title Part F: AUC0-t of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    NA
    (NA)
    75. Secondary Outcome
    Title Part F: AUC0-t of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    NA
    (NA)
    76. Secondary Outcome
    Title Part G: AUC0-t of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    77. Secondary Outcome
    Title Part H: AUC0-t of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    78. Secondary Outcome
    Title Part H: AUC0-t of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    79. Secondary Outcome
    Title Part I: AUC0-t of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    80. Secondary Outcome
    Title Part I: AUC0-t of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    81. Secondary Outcome
    Title Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    NA
    (NA)
    82. Secondary Outcome
    Title Part A: AUC(0-infinity) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    NA
    (NA)
    83. Secondary Outcome
    Title Part B: AUC(0-infinity) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    84. Secondary Outcome
    Title Part C: AUC(0-infinity) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    NA
    (NA)
    85. Secondary Outcome
    Title Part C: AUC(0-infinity) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    NA
    (NA)
    86. Secondary Outcome
    Title Part D: AUC(0-infinity) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    87. Secondary Outcome
    Title Part E: AUC(0-infinity) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    88. Secondary Outcome
    Title Part F: AUC(0-infinity) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    89. Secondary Outcome
    Title Part F: AUC(0-infinity) of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
    NA
    (NA)
    90. Secondary Outcome
    Title Part G: AUC(0-infinity) of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    91. Secondary Outcome
    Title Part H: AUC(0-infinity) of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    92. Secondary Outcome
    Title Part H: AUC(0-infinity) of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    93. Secondary Outcome
    Title Part I: AUC(0-infinity) of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    94. Secondary Outcome
    Title Part I: AUC(0-infinity) of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    95. Secondary Outcome
    Title Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 15 6
    Mean (Standard Deviation) [Microgram per milliliter]
    0.191953
    (0.1309536)
    0.342333
    (0.3301392)
    96. Secondary Outcome
    Title Part A: Ctau of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 9 4
    Mean (Standard Deviation) [Microgram per milliliter]
    33.6000
    (12.25194)
    29.8000
    (10.32570)
    97. Secondary Outcome
    Title Part B: Ctau of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 9
    Mean (Standard Deviation) [Microgram per milliliter]
    33.9778
    (9.89846)
    98. Secondary Outcome
    Title Part C: Ctau of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Mean (Standard Deviation) [Microgram per milliliter]
    0.161233
    (0.1072328)
    0.478714
    (0.4197538)
    99. Secondary Outcome
    Title Part C: Ctau of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 4 4
    Mean (Standard Deviation) [Microgram per milliliter]
    37.2750
    (16.78102)
    28.7500
    (9.47505)
    100. Secondary Outcome
    Title Part D: Ctau of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 4
    Mean (Standard Deviation) [Microgram per milliliter]
    36.5250
    (12.29834)
    101. Secondary Outcome
    Title Part E: Ctau of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    102. Secondary Outcome
    Title Part F: Ctau of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    103. Secondary Outcome
    Title Part F: Ctau of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    104. Secondary Outcome
    Title Part G: Ctau of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    105. Secondary Outcome
    Title Part H: Ctau of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    106. Secondary Outcome
    Title Part H: Ctau of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    107. Secondary Outcome
    Title Part I: Ctau of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    108. Secondary Outcome
    Title Part I: Ctau of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    109. Secondary Outcome
    Title Part A: Maximum Observed Plasma (Cmax) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 15 6
    Mean (Standard Deviation) [Microgram per milliliter]
    0.460600
    (0.2401100)
    0.625667
    (0.4547692)
    110. Secondary Outcome
    Title Part A: Cmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Mean (Standard Deviation) [Microgram per milliliter]
    158.6875
    (27.70251)
    138.9167
    (37.87930)
    111. Secondary Outcome
    Title Part B: Cmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Mean (Standard Deviation) [Microgram per milliliter]
    148.2000
    (31.27948)
    112. Secondary Outcome
    Title Part C: Cmax of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Mean (Standard Deviation) [Microgram per milliliter]
    0.243667
    (0.0889936)
    0.891571
    (0.4638897)
    113. Secondary Outcome
    Title Part C: Cmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Mean (Standard Deviation) [Microgram per milliliter]
    138.6667
    (24.14677)
    158.4857
    (48.36788)
    114. Secondary Outcome
    Title Part D: Cmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Mean (Standard Deviation) [Microgram per milliliter]
    188.5000
    (36.04858)
    115. Secondary Outcome
    Title Part E: Cmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    116. Secondary Outcome
    Title Part F: Cmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    117. Secondary Outcome
    Title Part F: Cmax of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    118. Secondary Outcome
    Title Part G: Cmax of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    119. Secondary Outcome
    Title Part H: Cmax of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    120. Secondary Outcome
    Title Part H: Cmax of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    121. Secondary Outcome
    Title Part I: Cmax of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    122. Secondary Outcome
    Title Part I: Cmax of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    123. Secondary Outcome
    Title Part A: Clearance After Oral Administration (CL/F) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 2
    Cycle 1, n=1,0
    28.5638
    (NA)
    Cycle 2, n=8,2
    16.6295
    (8.70836)
    10.2833
    (NA)
    124. Secondary Outcome
    Title Part A: Clearance After Intravenous Administration (CL) of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 2
    Cycle 4, n=7,2
    0.0090
    (0.00220)
    0.0110
    (NA)
    Cycle 5, n=8,1
    0.0081
    (0.00238)
    0.0071
    (NA)
    Cycle 11, n=4,0
    0.0072
    (0.00217)
    125. Secondary Outcome
    Title Part B: CL of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 10
    Cycle 4, n=10
    0.0098
    (0.00292)
    Cycle 5, n=8
    0.0082
    (0.00242)
    Cycle 11, n=6
    0.0092
    (0.00296)
    126. Secondary Outcome
    Title Part C: CL/F of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 2 4
    Cycle 2, n=2,4
    10.3777
    (NA)
    14.4947
    (8.40967)
    127. Secondary Outcome
    Title Part C: CL of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 6
    Cycle 4, n=5,5
    0.0100
    (0.00441)
    0.0104
    (0.00268)
    Cycle 5, n=5,6
    0.0082
    (0.00370)
    0.0082
    (0.00273)
    Cycle 11, n=4,2
    0.0079
    (0.00391)
    0.0086
    (NA)
    128. Secondary Outcome
    Title Part D: CL of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    0.0102
    (0.00210)
    Cycle 5, n=5
    0.0087
    (0.00169)
    Cycle 11, n=3
    0.0104
    (0.00100)
    129. Secondary Outcome
    Title Part E: CL of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Liter per hour]
    NA
    (NA)
    130. Secondary Outcome
    Title Part F: CL of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Liter per hour]
    NA
    (NA)
    131. Secondary Outcome
    Title Part F: CL of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Liter per hour]
    NA
    (NA)
    132. Secondary Outcome
    Title Part G: CL of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    133. Secondary Outcome
    Title Part H: CL of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    134. Secondary Outcome
    Title Part H: CL of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    135. Secondary Outcome
    Title Part I: CL of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    136. Secondary Outcome
    Title Part I: CL of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    137. Secondary Outcome
    Title Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 2
    Cycle 1, n=1,0
    380.1478
    (NA)
    Cycle 2, n=8,2
    716.1418
    (554.80278)
    487.8826
    (NA)
    138. Secondary Outcome
    Title Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 2
    Cycle 4, n=5,2
    5.6925
    (1.46062)
    10.3984
    (NA)
    Cycle 5, n=8,1
    6.8811
    (1.70545)
    6.3070
    (NA)
    Cycle 11, n=4,0
    7.4795
    (0.90952)
    139. Secondary Outcome
    Title Part B: Vz of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 10
    Cycle 4, n=10
    5.3661
    (2.01321)
    Cycle 5, n=8
    7.2627
    (2.43311)
    Cycle 11, n=6
    8.0529
    (3.64454)
    140. Secondary Outcome
    Title Part C: Vz/F of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 2 2
    Cycle 2, n=2,2
    551.4003
    (NA)
    559.3634
    (NA)
    141. Secondary Outcome
    Title Part C: Vz of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 6
    Cycle 4, n=5,5
    6.6462
    (2.66825)
    5.8922
    (2.93257)
    Cycle 5, n=4,6
    6.1698
    (1.73272)
    5.2066
    (1.07206)
    Cycle 11, n=4,2
    9.6347
    (4.05466)
    8.5098
    (NA)
    142. Secondary Outcome
    Title Part D: Vz of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    5.4955
    (1.89543)
    Cycle 5, n=5
    6.1542
    (1.57345)
    Cycle 11, n=3
    9.8356
    (0.99107)
    143. Secondary Outcome
    Title Part E: Vz of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Liter]
    NA
    (NA)
    144. Secondary Outcome
    Title Part F: Vz of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Liter]
    NA
    (NA)
    145. Secondary Outcome
    Title Part F: Vz of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Liter]
    NA
    (NA)
    146. Secondary Outcome
    Title Part G: Vz of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    147. Secondary Outcome
    Title Part H: Vz of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    148. Secondary Outcome
    Title Part H: Vz of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    149. Secondary Outcome
    Title Part I: Vz of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    150. Secondary Outcome
    Title Part I: Vz of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    151. Secondary Outcome
    Title Part A: AUC at Steady State (AUCss) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 2
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    16.3481
    (10.63803)
    29.4312
    (NA)
    152. Secondary Outcome
    Title Part A: AUCss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 3
    Cycle 4, n=7,2
    58598.5076
    (15328.61731)
    46122.3924
    (NA)
    Cycle 5, n=8,1
    135171.2753
    (43806.32512)
    141306.3782
    (NA)
    Cycle 11, n=4,0
    151575.3645
    (55194.65972)
    153. Secondary Outcome
    Title Part B: AUCss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 10
    Cycle 4, n=10
    55073.0926
    (15304.21896)
    Cycle 5, n=8
    130694.9752
    (33923.75772)
    Cycle 11, n=6
    117033.3612
    (33727.51653)
    154. Secondary Outcome
    Title Part C: AUCss of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 2 4
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    21.4926
    (NA)
    26.5006
    (14.61077)
    155. Secondary Outcome
    Title Part C: AUCss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 6
    Cycle 4, n=5,5
    55974.4268
    (16738.05254)
    50924.1510
    (13339.28085)
    Cycle 5, n=5,6
    137399.5881
    (45511.62023)
    131288.0291
    (36816.18787)
    Cycle 11, n=4,2
    147907.5379
    (60795.87607)
    119189.5905
    (NA)
    156. Secondary Outcome
    Title Part D: AUCss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    51140.4410
    (12597.07380)
    Cycle 5, n=5
    118845.3928
    (27874.98871)
    Cycle 11, n=3
    96800.1534
    (8871.32089)
    157. Secondary Outcome
    Title Part E: AUCss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    NA
    (NA)
    158. Secondary Outcome
    Title Part F: AUCss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    NA
    (NA)
    159. Secondary Outcome
    Title Part F: AUCss of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Hours*microgram per milliliter]
    NA
    (NA)
    160. Secondary Outcome
    Title Part G: AUCss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    161. Secondary Outcome
    Title Part H: AUCss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    162. Secondary Outcome
    Title Part H: AUCss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    163. Secondary Outcome
    Title Part I: AUCss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    164. Secondary Outcome
    Title Part I: AUCss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    165. Secondary Outcome
    Title Part A: Ctau at Steady State (Ctau,ss) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 11 6
    Cycle 2, n=11,6
    0.507900
    (0.3937657)
    0.622000
    (0.4523848)
    166. Secondary Outcome
    Title Part A: Ctau,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 1
    Cycle 4, n=8,1
    77.3625
    (28.55145)
    63.3000
    (NA)
    Cycle 5, n=8,1
    68.5500
    (34.63879)
    71.2000
    (NA)
    Cycle 11, n=4,0
    93.8000
    (47.28939)
    167. Secondary Outcome
    Title Part B: Ctau,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 9
    Cycle 4, n=9
    67.2444
    (24.15130)
    Cycle 5, n=8
    59.3000
    (16.75913)
    Cycle 11, n=6
    57.4833
    (20.98136)
    168. Secondary Outcome
    Title Part C: Ctau,ss of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 4
    Cycle 2, n=5,4
    0.484000
    (0.3511339)
    1.094250
    (0.7660576)
    169. Secondary Outcome
    Title Part C: Ctau,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 6
    Cycle 4, n=4,6
    70.4250
    (34.00896)
    64.2667
    (23.55315)
    Cycle 5, n=5,6
    82.9800
    (43.98252)
    53.1500
    (24.80538)
    Cycle 11, n=3,2
    105.4667
    (22.28909)
    60.9500
    (NA)
    170. Secondary Outcome
    Title Part D: Ctau,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    53.5200
    (13.87271)
    Cycle 5, n=5
    48.0800
    (23.95343)
    Cycle 11, n=3
    43.3000
    (4.80729)
    171. Secondary Outcome
    Title Part E: Ctau,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    172. Secondary Outcome
    Title Part F: Ctau,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    173. Secondary Outcome
    Title Part F: Ctau,ss of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    174. Secondary Outcome
    Title Part G: Ctau,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    175. Secondary Outcome
    Title Part H: Ctau,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    176. Secondary Outcome
    Title Part H: Ctau,ss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    177. Secondary Outcome
    Title Part I: Ctau,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    178. Secondary Outcome
    Title Part I: Ctau,ss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    179. Secondary Outcome
    Title Part A: Cmax at Steady State (Cmax,ss) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 10 3
    Cycle 2, n=10,3
    0.925900
    (0.6661597)
    1.706667
    (0.0838650)
    Cycle 5, n=7,0
    0.839071
    (0.6183628)
    Cycle 11, n=2,0
    0.768000
    (NA)
    180. Secondary Outcome
    Title Part A: Cmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 9 4
    Cycle 4, n=9,4
    222.5556
    (51.37633)
    178.5000
    (26.18524)
    Cycle 5, n=8,1
    393.8750
    (100.81729)
    319.0000
    (NA)
    Cycle 11, n=5,0
    405.4000
    (103.69812)
    181. Secondary Outcome
    Title Part B: Cmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 10
    Cycle 4, n=10
    225.8000
    (51.71460)
    Cycle 5, n=9
    421.1111
    (114.84603)
    Cycle 11, n=6
    446.6667
    (160.53868)
    182. Secondary Outcome
    Title Part C: Cmax,ss of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 4 4
    Cycle 2, n=4,4
    0.854500
    (0.3934637)
    1.404750
    (0.6642366)
    Cycle 5, n=4,3
    0.709750
    (0.2693788)
    1.073667
    (0.5474124)
    Cycle 11, n=3,1
    0.468333
    (0.1418955)
    0.638000
    (NA)
    183. Secondary Outcome
    Title Part C: Cmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 7
    Cycle 4, n=5,7
    234.4000
    (31.76948)
    227.1429
    (42.65923)
    Cycle 5, n=5,6
    325.2000
    (73.90332)
    417.3333
    (139.40397)
    Cycle 11, n=4,2
    349.7500
    (111.53886)
    321.0000
    (NA)
    184. Secondary Outcome
    Title Part D: Cmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    256.8000
    (76.90709)
    Cycle 5, n=5
    416.0000
    (89.43433)
    Cycle 11, n=4
    429.7500
    (72.86231)
    185. Secondary Outcome
    Title Part E: Cmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    186. Secondary Outcome
    Title Part F: Cmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    187. Secondary Outcome
    Title Part F: Cmax,ss of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Microgram per milliliter]
    NA
    (NA)
    188. Secondary Outcome
    Title Part G: Cmax,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    189. Secondary Outcome
    Title Part H: Cmax,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    190. Secondary Outcome
    Title Part H: Cmax,ss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    191. Secondary Outcome
    Title Part I: Cmax,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    192. Secondary Outcome
    Title Part I: Cmax,ss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    193. Secondary Outcome
    Title Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 15 6
    Median (Full Range) [Hours]
    2.250
    4.083
    194. Secondary Outcome
    Title Part A: Tmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 16 6
    Median (Full Range) [Hours]
    0.817
    1.750
    195. Secondary Outcome
    Title Part B: Tmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 14
    Median (Full Range) [Hours]
    1.000
    196. Secondary Outcome
    Title Part C: Tmax of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Median (Full Range) [Hours]
    3.975
    4.050
    197. Secondary Outcome
    Title Part C: Tmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 6 7
    Median (Full Range) [Hours]
    1.200
    0.583
    198. Secondary Outcome
    Title Part D: Tmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 6
    Median (Full Range) [Hours]
    1.250
    199. Secondary Outcome
    Title Part E: Tmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Median (Full Range) [Hours]
    NA
    200. Secondary Outcome
    Title Part F: Tmax of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Median (Full Range) [Hours]
    NA
    201. Secondary Outcome
    Title Part F: Tmax of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Median (Full Range) [Hours]
    NA
    202. Secondary Outcome
    Title Part G: Tmax of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    203. Secondary Outcome
    Title Part H: Tmax of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    204. Secondary Outcome
    Title Part H: Tmax of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    205. Secondary Outcome
    Title Part I: Tmax of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    206. Secondary Outcome
    Title Part I: Tmax of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    207. Secondary Outcome
    Title Part A: Tmax at Steady State (Tmax,ss) of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 10 3
    Cycle 2, n=10,3
    4.008
    2.250
    Cycle 5, n=7,0
    2.000
    Cycle 11, n=2,0
    1.817
    208. Secondary Outcome
    Title Part A: Tmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 9 4
    Cycle 4, n=9,4
    1.500
    1.300
    Cycle 5, n=8,1
    0.625
    2.783
    Cycle 11, n=5,0
    0.567
    209. Secondary Outcome
    Title Part B: Tmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 10
    Cycle 4, n=10
    0.575
    Cycle 5, n=9
    1.500
    Cycle 11, n=6
    0.542
    210. Secondary Outcome
    Title Part C: Tmax,ss of Niraparib
    Description Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 4 4
    Cycle 2, n=4,4
    4.950
    3.958
    Cycle 5, n=4,3
    2.158
    1.967
    Cycle 11, n=3,1
    2.000
    2.083
    211. Secondary Outcome
    Title Part C: Tmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 7
    Cycle 4, n=5,7
    1.517
    0.617
    Cycle 5, n=5,6
    2.083
    0.825
    Cycle 11, n=4,2
    2.000
    2.417
    212. Secondary Outcome
    Title Part D: Tmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    0.500
    Cycle 5, n=5
    0.550
    Cycle 11, n=4
    0.500
    213. Secondary Outcome
    Title Part E: Tmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Median (Full Range) [Hours]
    NA
    214. Secondary Outcome
    Title Part F: Tmax,ss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Median (Full Range) [Hours]
    NA
    215. Secondary Outcome
    Title Part F: Tmax,ss of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Median (Full Range) [Hours]
    NA
    216. Secondary Outcome
    Title Part G: Tmax,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    217. Secondary Outcome
    Title Part H: Tmax,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    218. Secondary Outcome
    Title Part H: Tmax,ss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    219. Secondary Outcome
    Title Part I: Tmax,ss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    220. Secondary Outcome
    Title Part I: Tmax,ss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    221. Secondary Outcome
    Title Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part A: TSR-042 and Niraparib 200 mg QD Part A: TSR-042 and Niraparib 300 mg QD
    Arm/Group Description 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. 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.
    Measure Participants 8 2
    Cycle 4, n=5,2
    5.5647
    (1.36694)
    9.8680
    (NA)
    Cycle 5, n=8,1
    6.6580
    (1.53521)
    5.9659
    (NA)
    Cycle 11, n=4,0
    7.3107
    (0.96007)
    222. Secondary Outcome
    Title Part B: Vss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part B: TSR-042 and Carboplatin-paclitaxel
    Arm/Group Description 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.
    Measure Participants 10
    Cycle 4, n=10
    5.1893
    (1.80311)
    Cycle 5, n=8
    6.7701
    (2.31992)
    Cycle 11, n=6
    7.4351
    (2.78481)
    223. Secondary Outcome
    Title Part C: Vss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
    Arm/Group Description 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. 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.
    Measure Participants 5 6
    Cycle 4, n=5,5
    6.4567
    (2.68944)
    5.5177
    (2.39652)
    Cycle 5, n=4,6
    6.2405
    (1.79539)
    4.8035
    (0.72905)
    Cycle 11, n=4,2
    8.9478
    (3.05769)
    7.7750
    (NA)
    224. Secondary Outcome
    Title Part D: Vss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
    Arm/Group Title Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
    Arm/Group Description 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.
    Measure Participants 5
    Cycle 4, n=5
    5.1493
    (1.58340)
    Cycle 5, n=5
    5.6399
    (1.41478)
    Cycle 11, n=3
    8.0614
    (0.48037)
    225. Secondary Outcome
    Title Part E: Vss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part E: TSR-042 and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 2
    Mean (Standard Deviation) [Liter]
    NA
    (NA)
    226. Secondary Outcome
    Title Part F: Vss of TSR-042
    Description Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Liter]
    NA
    (NA)
    227. Secondary Outcome
    Title Part F: Vss of TSR-022
    Description Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population.
    Arm/Group Title Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
    Arm/Group Description 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).
    Measure Participants 1
    Mean (Standard Deviation) [Liter]
    NA
    (NA)
    228. Secondary Outcome
    Title Part G: Vss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part G.
    Arm/Group Title Part G: TSR-042 and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    229. Secondary Outcome
    Title Part H: Vss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    230. Secondary Outcome
    Title Part H: Vss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part H.
    Arm/Group Title Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
    Arm/Group Description 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.
    Measure Participants 0
    231. Secondary Outcome
    Title Part I: Vss of TSR-042
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0
    232. Secondary Outcome
    Title Part I: Vss of TSR-022
    Description Blood samples were planned to be collected at indicated time points.
    Time Frame Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

    Outcome Measure Data

    Analysis Population Description
    PK Population. Data was not collected as no participants were enrolled in Part I.
    Arm/Group Title Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
    Arm/Group Description 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).
    Measure Participants 0

    Adverse Events

    Time Frame All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A and B; up to 22.5 months in Part C; up to 9.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F
    Adverse Event Reporting Description Safety Population. 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. The results presented are based on primary analysis up to maximum 28.5 months. Data collection is still on-going and additional results will be provided after study completion.
    Arm/Group Title 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
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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). 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).
    All Cause Mortality
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/16 (25%) 4/6 (66.7%) 7/14 (50%) 1/6 (16.7%) 4/7 (57.1%) 1/6 (16.7%) 1/2 (50%) 0/1 (0%)
    Serious Adverse Events
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/16 (68.8%) 4/6 (66.7%) 9/14 (64.3%) 3/6 (50%) 3/7 (42.9%) 3/6 (50%) 2/2 (100%) 0/1 (0%)
    Blood and lymphatic system disorders
    Anaemia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Neutropenia 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Thrombocytopenia 2/16 (12.5%) 2 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cardiac disorders
    Atrial fibrillation 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Atrioventricular block complete 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ileus 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Intestinal obstruction 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    General disorders
    Asthenia 0/16 (0%) 0 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Fatigue 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Mucosal inflammation 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Non-cardiac chest pain 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sudden death 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hepatobiliary disorders
    Hepatitis 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Infections and infestations
    Appendicitis perforated 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastroenteritis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumonia 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Sinusitis 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Staphylococcal abscess 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Injury, poisoning and procedural complications
    Procedural pain 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypercalcaemia 1/16 (6.3%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hyponatraemia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 3 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 2 0/2 (0%) 0 0/1 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Nervous system disorders
    Haemorrhage intracranial 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Posterior reversible encephalopathy syndrome 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Vertebral artery dissection 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Renal and urinary disorders
    Hydronephrosis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Urinary retention 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dyspnoea 2/16 (12.5%) 2 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypoxia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pleural effusion 2/16 (12.5%) 4 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumonia aspiration 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumonitis 0/16 (0%) 0 1/6 (16.7%) 2 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumothorax 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pulmonary embolism 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Respiratory failure 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Other (Not Including Serious) Adverse Events
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/16 (100%) 6/6 (100%) 14/14 (100%) 5/6 (83.3%) 7/7 (100%) 6/6 (100%) 2/2 (100%) 1/1 (100%)
    Blood and lymphatic system disorders
    Anaemia 4/16 (25%) 13 3/6 (50%) 9 10/14 (71.4%) 27 2/6 (33.3%) 9 5/7 (71.4%) 10 5/6 (83.3%) 10 2/2 (100%) 6 1/1 (100%) 12
    Febrile neutropenia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Haemolysis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Lymphadenopathy 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Neutropenia 1/16 (6.3%) 4 1/6 (16.7%) 2 6/14 (42.9%) 9 1/6 (16.7%) 1 1/7 (14.3%) 1 4/6 (66.7%) 15 0/2 (0%) 0 0/1 (0%) 0
    Thrombocytopenia 4/16 (25%) 7 2/6 (33.3%) 2 2/14 (14.3%) 3 2/6 (33.3%) 3 2/7 (28.6%) 5 2/6 (33.3%) 19 0/2 (0%) 0 1/1 (100%) 2
    Cardiac disorders
    Atrial fibrillation 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Left ventricular hypertrophy 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Palpitations 2/16 (12.5%) 2 0/6 (0%) 0 1/14 (7.1%) 1 1/6 (16.7%) 1 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Sinus tachycardia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Tachycardia 2/16 (12.5%) 2 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 1/1 (100%) 1
    Ear and labyrinth disorders
    Deafness 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Ear discomfort 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ear pain 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vertigo 2/16 (12.5%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Endocrine disorders
    Hyperthyroidism 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypothyroidism 2/16 (12.5%) 3 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 2/7 (28.6%) 2 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Eye disorders
    Blepharitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dacryostenosis acquired 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Diplopia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Eye haemorrhage 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ocular hyperaemia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ophthalmoplegia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vision blurred 0/16 (0%) 0 0/6 (0%) 0 3/14 (21.4%) 3 1/6 (16.7%) 1 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Visual impairment 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Abdominal distension 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Abdominal pain 4/16 (25%) 5 1/6 (16.7%) 1 2/14 (14.3%) 2 1/6 (16.7%) 1 1/7 (14.3%) 1 3/6 (50%) 4 0/2 (0%) 0 0/1 (0%) 0
    Abdominal pain upper 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 1/1 (100%) 1
    Anal fistula 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Ascites 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Colitis 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Constipation 5/16 (31.3%) 5 2/6 (33.3%) 2 4/14 (28.6%) 6 4/6 (66.7%) 4 4/7 (57.1%) 4 3/6 (50%) 6 2/2 (100%) 2 0/1 (0%) 0
    Dental caries 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Diarrhoea 0/16 (0%) 0 0/6 (0%) 0 6/14 (42.9%) 7 2/6 (33.3%) 2 4/7 (57.1%) 4 4/6 (66.7%) 21 0/2 (0%) 0 0/1 (0%) 0
    Diarrhoea haemorrhagic 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dry mouth 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dyspepsia 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Dysphagia 2/16 (12.5%) 3 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Faeces hard 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Flatulence 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Gastric disorder 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastrointestinal haemorrhage 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastrooesophageal reflux disease 1/16 (6.3%) 1 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Haematochezia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Haemorrhoids 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hiatus hernia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypertrophy of tongue papillae 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Inguinal hernia 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Lower gastrointestinal haemorrhage 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Mouth haemorrhage 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Nausea 8/16 (50%) 10 4/6 (66.7%) 5 4/14 (28.6%) 4 3/6 (50%) 4 4/7 (57.1%) 6 3/6 (50%) 9 2/2 (100%) 4 0/1 (0%) 0
    Oesophagitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oral discomfort 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oral pain 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Peptic ulcer 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Stomatitis 1/16 (6.3%) 1 1/6 (16.7%) 1 1/14 (7.1%) 1 1/6 (16.7%) 1 2/7 (28.6%) 4 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Tooth loss 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vomiting 5/16 (31.3%) 11 2/6 (33.3%) 2 2/14 (14.3%) 2 1/6 (16.7%) 2 4/7 (57.1%) 4 2/6 (33.3%) 4 1/2 (50%) 2 0/1 (0%) 0
    General disorders
    Asthenia 0/16 (0%) 0 0/6 (0%) 0 3/14 (21.4%) 4 1/6 (16.7%) 1 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Chest discomfort 0/16 (0%) 0 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Chest pain 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Chills 1/16 (6.3%) 1 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cyst rupture 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Fatigue 4/16 (25%) 4 3/6 (50%) 3 7/14 (50%) 9 2/6 (33.3%) 2 4/7 (57.1%) 4 4/6 (66.7%) 7 1/2 (50%) 1 1/1 (100%) 2
    Gait disturbance 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Localised oedema 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Malaise 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Mucosal inflammation 2/16 (12.5%) 2 0/6 (0%) 0 1/14 (7.1%) 1 2/6 (33.3%) 2 2/7 (28.6%) 5 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Non-cardiac chest pain 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oedema peripheral 2/16 (12.5%) 2 1/6 (16.7%) 1 3/14 (21.4%) 5 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pain 1/16 (6.3%) 1 1/6 (16.7%) 1 1/14 (7.1%) 2 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 1/1 (100%) 1
    Peripheral swelling 1/16 (6.3%) 1 0/6 (0%) 0 1/14 (7.1%) 2 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pyrexia 2/16 (12.5%) 3 1/6 (16.7%) 1 2/14 (14.3%) 3 2/6 (33.3%) 2 1/7 (14.3%) 1 2/6 (33.3%) 3 0/2 (0%) 0 0/1 (0%) 0
    Swelling 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Swelling face 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Temperature intolerance 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hepatobiliary disorders
    Autoimmune hepatitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Immune system disorders
    Seasonal allergy 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Infections and infestations
    Acute sinusitis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 3 0/2 (0%) 0 0/1 (0%) 0
    Bacterial vaginosis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Bacterial vulvovaginitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Candida infection 2/16 (12.5%) 2 0/6 (0%) 0 4/14 (28.6%) 4 0/6 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cellulitis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/6 (16.7%) 2 0/2 (0%) 0 0/1 (0%) 0
    Conjunctivitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cystitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Dacryocystitis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Folliculitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Gastroenteritis viral 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Herpes zoster 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Influenza 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Kidney infection 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Lung abscess 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 2 0/1 (0%) 0
    Nasopharyngitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Onychomycosis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oral candidiasis 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumonia 1/16 (6.3%) 2 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sepsis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Sinusitis 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 2/6 (33.3%) 3 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Stoma site infection 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Upper respiratory tract infection 3/16 (18.8%) 4 0/6 (0%) 0 0/14 (0%) 0 2/6 (33.3%) 2 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Urinary tract infection 1/16 (6.3%) 1 0/6 (0%) 0 4/14 (28.6%) 6 1/6 (16.7%) 1 0/7 (0%) 0 2/6 (33.3%) 2 0/2 (0%) 0 1/1 (100%) 1
    Viral pharyngitis 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vulvovaginal candidiasis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Fall 0/16 (0%) 0 1/6 (16.7%) 1 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Foot fracture 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Infusion related reaction 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Postoperative ileus 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Radiation injury 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Recall phenomenon 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Skin laceration 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/6 (33.3%) 3 0/2 (0%) 0 0/1 (0%) 0
    Tooth fracture 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Investigations
    Activated partial thromboplastin time prolonged 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Alanine aminotransferase increased 1/16 (6.3%) 1 0/6 (0%) 0 2/14 (14.3%) 5 2/6 (33.3%) 4 2/7 (28.6%) 4 1/6 (16.7%) 1 1/2 (50%) 3 0/1 (0%) 0
    Amylase increased 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 2/6 (33.3%) 6 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Aspartate aminotransferase increased 3/16 (18.8%) 6 1/6 (16.7%) 1 2/14 (14.3%) 5 0/6 (0%) 0 2/7 (28.6%) 4 1/6 (16.7%) 1 1/2 (50%) 1 0/1 (0%) 0
    Blood alkaline phosphatase increased 2/16 (12.5%) 4 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 2 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Blood bilirubin increased 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Blood creatinine increased 2/16 (12.5%) 4 2/6 (33.3%) 2 0/14 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood folate decreased 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood potassium decreased 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood pressure increased 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood testosterone decreased 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood thyroid stimulating hormone decreased 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood thyroid stimulating hormone increased 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Blood uric acid increased 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Breath sounds abnormal 1/16 (6.3%) 1 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cardiac murmur 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    International normalised ratio increased 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 4 0/1 (0%) 0
    Lymphocyte count decreased 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 6 0/1 (0%) 0
    Neutrophil count decreased 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 1/2 (50%) 1 1/1 (100%) 3
    Platelet count decreased 0/16 (0%) 0 1/6 (16.7%) 4 0/14 (0%) 0 0/6 (0%) 0 2/7 (28.6%) 6 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Tri-iodothyronine decreased 1/16 (6.3%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vitamin B12 decreased 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Weight decreased 4/16 (25%) 4 1/6 (16.7%) 1 1/14 (7.1%) 1 1/6 (16.7%) 1 2/7 (28.6%) 2 3/6 (50%) 6 1/2 (50%) 2 1/1 (100%) 1
    Weight increased 1/16 (6.3%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    White blood cell count decreased 2/16 (12.5%) 4 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 1/7 (14.3%) 1 1/6 (16.7%) 2 1/2 (50%) 4 1/1 (100%) 5
    Metabolism and nutrition disorders
    Decreased appetite 2/16 (12.5%) 3 0/6 (0%) 0 5/14 (35.7%) 6 0/6 (0%) 0 3/7 (42.9%) 3 1/6 (16.7%) 1 1/2 (50%) 1 0/1 (0%) 0
    Dehydration 4/16 (25%) 4 1/6 (16.7%) 1 4/14 (28.6%) 4 0/6 (0%) 0 1/7 (14.3%) 1 3/6 (50%) 8 2/2 (100%) 4 1/1 (100%) 1
    Fluid retention 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypercalcaemia 1/16 (6.3%) 5 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hyperglycaemia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 3 0/1 (0%) 0
    Hyperphosphataemia 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypoalbuminaemia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Hypoglycaemia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Hypokalaemia 5/16 (31.3%) 8 0/6 (0%) 0 5/14 (35.7%) 6 0/6 (0%) 0 2/7 (28.6%) 2 3/6 (50%) 5 0/2 (0%) 0 1/1 (100%) 1
    Hypomagnesaemia 2/16 (12.5%) 3 0/6 (0%) 0 4/14 (28.6%) 9 0/6 (0%) 0 2/7 (28.6%) 3 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Hyponatraemia 2/16 (12.5%) 2 3/6 (50%) 3 0/14 (0%) 0 1/6 (16.7%) 4 1/7 (14.3%) 1 1/6 (16.7%) 1 1/2 (50%) 1 0/1 (0%) 0
    Iron deficiency 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Malnutrition 1/16 (6.3%) 1 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/16 (6.3%) 2 0/6 (0%) 0 6/14 (42.9%) 11 1/6 (16.7%) 1 1/7 (14.3%) 1 3/6 (50%) 3 1/2 (50%) 1 0/1 (0%) 0
    Arthritis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Back pain 2/16 (12.5%) 3 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Bone pain 1/16 (6.3%) 1 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Flank pain 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Joint stiffness 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Muscle spasms 1/16 (6.3%) 1 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Muscular weakness 0/16 (0%) 0 2/6 (33.3%) 2 1/14 (7.1%) 1 0/6 (0%) 0 1/7 (14.3%) 1 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Musculoskeletal chest pain 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 2 1/7 (14.3%) 1 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Musculoskeletal pain 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Myalgia 2/16 (12.5%) 2 0/6 (0%) 0 2/14 (14.3%) 4 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Neck pain 1/16 (6.3%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Osteoporosis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pain in extremity 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 1/7 (14.3%) 1 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Rotator cuff syndrome 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Soft tissue mass 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Tendonitis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Tumour pain 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Nervous system disorders
    Autonomic neuropathy 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Balance disorder 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Carpal tunnel syndrome 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Disturbance in attention 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Dizziness 1/16 (6.3%) 1 1/6 (16.7%) 1 4/14 (28.6%) 5 1/6 (16.7%) 1 0/7 (0%) 0 2/6 (33.3%) 2 1/2 (50%) 2 0/1 (0%) 0
    Dizziness postural 1/16 (6.3%) 1 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Dysgeusia 1/16 (6.3%) 1 1/6 (16.7%) 1 3/14 (21.4%) 3 0/6 (0%) 0 1/7 (14.3%) 1 1/6 (16.7%) 1 1/2 (50%) 2 0/1 (0%) 0
    Encephalopathy 0/16 (0%) 0 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Headache 3/16 (18.8%) 3 1/6 (16.7%) 1 3/14 (21.4%) 3 4/6 (66.7%) 5 1/7 (14.3%) 1 1/6 (16.7%) 2 0/2 (0%) 0 0/1 (0%) 0
    Hemiparesis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hyperreflexia 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypoaesthesia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Memory impairment 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Neuralgia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Neuropathy peripheral 0/16 (0%) 0 0/6 (0%) 0 4/14 (28.6%) 6 2/6 (33.3%) 2 0/7 (0%) 0 2/6 (33.3%) 2 0/2 (0%) 0 0/1 (0%) 0
    Paraesthesia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Peripheral motor neuropathy 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Peripheral sensory neuropathy 1/16 (6.3%) 1 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Post herpetic neuralgia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sciatica 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Somnolence 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Spinal cord compression 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Syncope 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Tremor 1/16 (6.3%) 1 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Product Issues
    Device malfunction 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Device occlusion 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Psychiatric disorders
    Anxiety 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Confusional state 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/6 (33.3%) 2 0/2 (0%) 0 0/1 (0%) 0
    Depression 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Disorientation 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hallucination, visual 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Insomnia 3/16 (18.8%) 3 2/6 (33.3%) 2 4/14 (28.6%) 4 0/6 (0%) 0 2/7 (28.6%) 2 0/6 (0%) 0 1/2 (50%) 1 0/1 (0%) 0
    Mental status changes 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sleep disorder 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Chronic kidney disease 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dysuria 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Haematuria 2/16 (12.5%) 3 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Incontinence 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Leukocyturia 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Nocturia 2/16 (12.5%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Proteinuria 1/16 (6.3%) 3 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 4/7 (57.1%) 9 3/6 (50%) 7 1/2 (50%) 2 0/1 (0%) 0
    Reproductive system and breast disorders
    Postmenopausal haemorrhage 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Pruritus genital 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vaginal haemorrhage 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vulvovaginal dryness 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial secretion retention 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Cough 4/16 (25%) 5 3/6 (50%) 4 3/14 (21.4%) 4 1/6 (16.7%) 1 2/7 (28.6%) 2 2/6 (33.3%) 3 0/2 (0%) 0 0/1 (0%) 0
    Dysphonia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dyspnoea 4/16 (25%) 6 1/6 (16.7%) 1 6/14 (42.9%) 7 2/6 (33.3%) 2 2/7 (28.6%) 3 3/6 (50%) 7 1/2 (50%) 1 0/1 (0%) 0
    Dyspnoea exertional 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 1/6 (16.7%) 1 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Epistaxis 0/16 (0%) 0 2/6 (33.3%) 2 1/14 (7.1%) 1 1/6 (16.7%) 1 1/7 (14.3%) 1 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Haemoptysis 0/16 (0%) 0 2/6 (33.3%) 2 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypoxia 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Immune-mediated pneumonitis 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Interstitial lung disease 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Nasal congestion 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Nasal dryness 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Oropharyngeal pain 2/16 (12.5%) 2 1/6 (16.7%) 1 2/14 (14.3%) 2 1/6 (16.7%) 1 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pleural effusion 2/16 (12.5%) 3 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 2 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pneumonitis 1/16 (6.3%) 1 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Productive cough 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pulmonary embolism 1/16 (6.3%) 1 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Rhinitis allergic 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Rhinorrhoea 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sinus congestion 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Sputum discoloured 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Tachypnoea 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Upper airway obstruction 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Upper-airway cough syndrome 0/16 (0%) 0 1/6 (16.7%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Wheezing 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 0/16 (0%) 0 0/6 (0%) 0 8/14 (57.1%) 10 0/6 (0%) 0 1/7 (14.3%) 1 5/6 (83.3%) 6 0/2 (0%) 0 0/1 (0%) 0
    Dermatitis acneiform 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Dry skin 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Ecchymosis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Erythema 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hyperhidrosis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Intertrigo 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Nail discolouration 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Nail ridging 0/16 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Night sweats 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Petechiae 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pigmentation disorder 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pruritus 1/16 (6.3%) 1 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 2 0/2 (0%) 0 0/1 (0%) 0
    Psoriasis 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Purpura 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Rash 4/16 (25%) 6 1/6 (16.7%) 2 3/14 (21.4%) 8 0/6 (0%) 0 1/7 (14.3%) 2 2/6 (33.3%) 4 0/2 (0%) 0 1/1 (100%) 2
    Rash macular 1/16 (6.3%) 2 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Skin disorder 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/2 (0%) 0 0/1 (0%) 0
    Skin lesion 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Vascular disorders
    Deep vein thrombosis 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hot flush 1/16 (6.3%) 1 2/6 (33.3%) 2 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Hypertension 2/16 (12.5%) 3 1/6 (16.7%) 1 0/14 (0%) 0 4/6 (66.7%) 4 2/7 (28.6%) 2 3/6 (50%) 5 0/2 (0%) 0 0/1 (0%) 0
    Hypotension 2/16 (12.5%) 3 1/6 (16.7%) 1 1/14 (7.1%) 1 1/6 (16.7%) 1 0/7 (0%) 0 2/6 (33.3%) 3 1/2 (50%) 1 1/1 (100%) 1
    Orthostatic hypotension 0/16 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Pallor 0/16 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0
    Venous thrombosis limb 0/16 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/2 (0%) 0 0/1 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email GSKClinicalSupportHD@gsk.com
    Responsible Party:
    Tesaro, Inc.
    ClinicalTrials.gov Identifier:
    NCT03307785
    Other Study ID Numbers:
    • 213351
    • 3000-01-002
    First Posted:
    Oct 12, 2017
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022