Trial Outcomes & Findings for Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer (NCT NCT02769962)

Last Updated: 2025-07-28

Results Overview

MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

First 28 days

Results posted on

2025-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Overall Study STARTED	3	5	3	6	7	13	4	4
Overall Study COMPLETED	3	5	3	6	7	11	3	3
Overall Study NOT COMPLETED	0	0	0	0	0	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Overall Study Physician Decision	0	0	0	0	0	1	0	1
Overall Study Refused further treatment	0	0	0	0	0	1	1	0

Baseline Characteristics

Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) n=3 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=5 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=13 Participants "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=4 Participants "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg n=4 Participants "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	29 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	16 Participants n=42 Participants
Age, Continuous	61.33 years STANDARD_DEVIATION 13.32 • n=5 Participants	54.2 years STANDARD_DEVIATION 2.77 • n=7 Participants	61.33 years STANDARD_DEVIATION 4.51 • n=5 Participants	58.5 years STANDARD_DEVIATION 7.45 • n=4 Participants	62.43 years STANDARD_DEVIATION 7.89 • n=21 Participants	63.54 years STANDARD_DEVIATION 8.44 • n=8 Participants	54.25 years STANDARD_DEVIATION 7.85 • n=8 Participants	71.25 years STANDARD_DEVIATION 10.31 • n=24 Participants	61.22 years STANDARD_DEVIATION 8.8 • n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	22 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	23 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	13 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	43 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	12 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	37 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	7 participants n=21 Participants	13 participants n=8 Participants	4 participants n=8 Participants	4 participants n=24 Participants	45 participants n=42 Participants

PRIMARY outcome

Timeframe: First 28 days

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of EP0057 (CLRX101) in Participants With Refractory Cancers.	12 mg/m^2	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: First 28 days

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Olaparib in Participants With Refractory Cancers.	250 mg	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: First 28 days

Population: Only 23/45 participants were analyzed because DLTs are only completed during phase I. There were only 23 participants in phase I.

DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity, and any Grade 3-4 non-hematologic toxicity except fatigue/asthenia \<2 weeks in duration).

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=4 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Number of Dose Limiting Toxicities (DLTs) During the First Cycle	0 toxicities	0 toxicities	0 toxicities	2 toxicities	1 toxicities	—	—	—

PRIMARY outcome

Timeframe: 16 weeks

Population: 10/13 participants with small cell lung cancer were analyzed because PFS was only calculated for evaluable participants.

Determine if slightly more than 50% of participants may be identified as being without progression by 16 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and 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. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	All Participants n=10 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Expansion: Progression Free Survival (PFS) Rate in the Combination of Olaparib Plus EP0057 (CLRX101) at 16 Weeks in Small Cell Lung Cancer (SCLC) Participants	2 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 8 weeks

Population: 3/4 participants with urothelial carcinoma were analyzed because only 3 of the 4 participants were evaluable; to analyze a response you can only use evaluable participants.

Overall response rate is the best response recorded from the start of the treatment until disease progression/recurrence. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and 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. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Urothelial Carcinoma	1 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 weeks

Population: 3/4 participants with metastatic castration-resistant prostate cancer were analyzed because only 3 of the 4 participants were evaluable; to analyze a response you can only use evaluable participants.

Determine if slightly more than 50% of participants may be identified as being without progression by 12 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and 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. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)	1 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Start of treatment through 30 days post last dose, an average of 8.26 months.

Occurrence is captured by subjective and objective data via participant assessment ad self-report. Toxicities including toxicity type and severity (Grades 1, 2, 3, and/or 4) with probable association to study regimen in participants on Expansion cohorts was measured by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.

Outcome measures

Outcome measures
Measure	All Participants n=13 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=4 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=4 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Abdominal pain	1 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Alopecia	1 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Anemia	1 toxicities	0 toxicities	2 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Anorexia	1 toxicities	1 toxicities	2 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Constipation	2 toxicities	0 toxicities	2 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Creatinine increased	0 toxicities	3 toxicities	2 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Cystitis noninfective	1 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Diarrhea	3 toxicities	1 toxicities	4 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Dysgeusia	2 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Fatigue	3 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Fever	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Gastroesophageal reflux disease	1 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Headache	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Hematuria	1 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Hypokalemia	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Hyponatremia	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Mucositis oral	0 toxicities	1 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Myalgia	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Nail discoloration	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Nausea	5 toxicities	2 toxicities	2 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Neutrophil count decreased	1 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Platelet count decreased	3 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Stomach pain	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Urinary frequency	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Urinary tract pain	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 Vomiting	4 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 1 White blood cell decreased	5 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Abdominal pain	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Alopecia	2 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Anemia	11 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Anorexia	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Constipation	1 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Creatinine increased	0 toxicities	4 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Cystitis noninfective	1 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Diarrhea	2 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Fatigue	3 toxicities	1 toxicities	3 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Gastroesophageal reflux disease	1 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Infections and infestations - Other specify, oral candidiasis	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Lymphocyte count decreased	9 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Mobitz (type) II atrioventricular block	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Nausea	1 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Neutrophil count decreased	4 toxicities	1 toxicities	2 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Platelet count decreased	1 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Proteinuria	1 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Pruritus	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Urinary retention	0 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 Urinary tract infection	0 toxicities	0 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 2 White blood cell decreased	4 toxicities	1 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Anemia	6 toxicities	4 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Anorexia	0 toxicities	2 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Fatigue	0 toxicities	1 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Lymphocyte count decreased	7 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Mobitz (type) II atrioventricular block	0 toxicities	0 toxicities	1 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Platelet count decreased	1 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Thromboembolic event	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 Urinary tract infection	0 toxicities	1 toxicities	0 toxicities	—	—	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts Grade 3 White blood cell count decreased	0 toxicities	1 toxicities	1 toxicities	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 3 months post-treatment, up until date of death from any cause or an average of 9.57 months.

Population: 16/21 participants in the expansion cohort were analyzed because this was the number of evaluable participants.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome measures
Measure	All Participants n=10 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Progression-free Survival (PFS) on Expansion Cohorts	1.97 Months Interval 0.95 to 10.41	1.90 Months Interval 1.37 to 7.32	8.67 Months Interval 1.8 to 19.48	—	—	—	—	—

SECONDARY outcome

Timeframe: Duration of time from start of treatment to time of progression or death, whichever occurs first, up to 2.5 years

Population: 18/24 participants with solid tumors were analyzed because these were the evaluable participants.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and 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. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=4 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=5 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Progression-free Survival (PFS) of the Combination	4.71 Months Interval 2.63 to 7.18	8.37 Months Interval 3.16 to 30.36	8.37 Months Interval 3.16 to 30.36	4.154 Months Interval 2.24 to 6.59	13.18 Months Interval 3.82 to 22.35	—	—	—

SECONDARY outcome

Timeframe: Date of on-study to the date of death from any cause or last follow up, up to 2.5 years

Population: 34/45 participants were analyzed because these were the evaluable participants.

OS is defined as the date of on-study to the date of death from any cause or last follow up.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=4 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=5 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=10 Participants "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=3 Participants "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg n=3 Participants "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Overall Survival (OS) of the Combination	2.07 Months Interval 1.91 to 2.83	2.30 Months Interval 1.87 to 5.53	2.57 Months Interval 2.34 to 6.09	1.54 Months Interval 0.98 to 3.26	9.72 Months Interval 2.04 to 13.87	4.15 Months Interval 1.54 to 73.16	5.88 Months Interval 4.59 to 25.45	14.02 Months Interval 12.91 to 19.48

SECONDARY outcome

Timeframe: 40.71 weeks from start of treatment to best response date

Population: 1/4 participants were analyzed because they were not evaluable.

PSA levels in blood, date of cycle 1, Day 1 (C1D1) - Best response date. PSA levels were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Normal PSA level is ≤6.5 ng/mL for age 70-79 and an elevated level is not interpreted good or bad; a very high number is a strong indicator of prostate cancer; since this is a cohort of prostate cancer an elevated number is expected. Partial Response was assessed by the Response Evaluation Criteria in Solid Tumors in Solid Tumors (RECIST) guideline (version 1.1) and Prostate Cancer Clinical Trials Working Group criteria (PCWG2). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) With an 80% Confidence Interval C1D1 PSA	75.35 ng/mL An 80% confidence interval cannot be calculated from just one observation because there is no way to estimate variability or the spread of the data.	—	—	—	—	—	—	—
Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) With an 80% Confidence Interval Best Response date PSA	32.14 ng/mL An 80% confidence interval cannot be calculated from just one observation because there is no way to estimate variability or the spread of the data.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 40.71 weeks from start of treatment to best response date.

PSA levels in blood were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Normal PSA level is ≤6.5 ng/mL for age 70-79 and an elevated level is not interpreted good or bad; a very high number is a strong indicator of prostate cancer; since this is a cohort of prostate cancer an elevated number is expected; it is noted that this number is decreased from the start of therapy. Partial Response was assessed by the Response Evaluation Criteria in Solid Tumors in Solid Tumors (RECIST) guideline (version 1.1) and Prostate Cancer Clinical Trials Working Group criteria (PCWG2). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) an 95% Confidence Interval C1D1 PSA	75.35 ng/mL A 95% confidence interval and median cannot be calculated from just one observation because there is no way to estimate variability or the spread of the data.	—	—	—	—	—	—	—
Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) an 95% Confidence Interval Best Response date PSA	32.14 ng/mL A 95% confidence interval and median cannot be calculated from just one observation because there is no way to estimate variability or the spread of the data.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline and after every 2 cycles up until the date of first documented progression or an average of average 11.09 months.

Population: 5/45 participants were analyzed because only 5/45 participants were evaluable.

DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. OS is determined from the start of treatment until death. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome measures
Measure	All Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=2 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=1 Participants "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=1 Participants "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg n=1 Participants "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Duration of Response (DOR) of the Combination	—	—	—	—	7.95 Months Interval 7.85 to 8.04	NA Months Interval 5.05 to Median and upper end of confidence of confidence interval cannot be estimated for one participant.	NA Months Interval 2.75 to Median and upper end of confidence of confidence interval cannot be estimated for one participant.	NA Months Interval 10.11 to Median and upper end of confidence of confidence interval cannot be estimated for one participant.

SECONDARY outcome

Timeframe: Start of treatment through 30 days post last dose, up to 3.99 months

Occurrence is captured by subjective and objective data via participant assessment and self-report. Toxicities including toxicity type and severity (Grades 1, 2, 3, and/or 4) with probable association to study regimen in participants on Expansion cohorts was measured by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event (AE).

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=5 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Abdominal pain	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Alanine aminotransferase increased	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Alkaline phosphatase increased	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Alopecia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	4 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Anemia	1 occurrences of toxicities	3 occurrences of toxicities	5 occurrences of toxicities	1 occurrences of toxicities	12 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Anorexia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Aspartate aminotransferase increased	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Bloating	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Constipation	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Cough	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Creatinine increased	1 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	5 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Cystitis noninfective	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Diarrhea	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Dizziness	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Dysgeusia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Dyspepsia	1 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Dysphagia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Fatigue	0 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 GGT increased	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Headache	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Hypokalemia	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	54 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Hypomagnesemia	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Lymphocyte count decreased	3 occurrences of toxicities	10 occurrences of toxicities	4 occurrences of toxicities	11 occurrences of toxicities	11 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Nausea	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	2 occurrences of toxicities	6 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Neutrophil count decreased	0 occurrences of toxicities	1 occurrences of toxicities	5 occurrences of toxicities	2 occurrences of toxicities	2 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Platelet count decreased	2 occurrences of toxicities	2 occurrences of toxicities	3 occurrences of toxicities	10 occurrences of toxicities	13 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Sore throat	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Urinary retention	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Urinary tract pain	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Vaginal pain	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 Vomiting	0 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 1 White blood cell decreased	1 occurrences of toxicities	3 occurrences of toxicities	10 occurrences of toxicities	3 occurrences of toxicities	12 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Abdominal pain	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Alopecia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Anemia	3 occurrences of toxicities	8 occurrences of toxicities	7 occurrences of toxicities	6 occurrences of toxicities	20 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Anorexia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Constipation	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Cough	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Creatinine increased	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Diarrhea	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Dyspepsia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Fatigue	1 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Gastroesophageal reflux disease	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Hypophosphatemia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Infusion related reaction	3 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Lung infection	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Lymphocyte count decreased	1 occurrences of toxicities	6 occurrences of toxicities	3 occurrences of toxicities	12 occurrences of toxicities	18 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Nausea	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Neutrophil count decreased	1 occurrences of toxicities	2 occurrences of toxicities	4 occurrences of toxicities	7 occurrences of toxicities	5 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Pain in extremity	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Platelet count decreased	2 occurrences of toxicities	1 occurrences of toxicities	3 occurrences of toxicities	3 occurrences of toxicities	2 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Sinus tachycardia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Upper respiratory infection	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Urinary tract infection	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Vaginal pain	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 Vomiting	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 2 White blood cell decreased	2 occurrences of toxicities	2 occurrences of toxicities	6 occurrences of toxicities	8 occurrences of toxicities	9 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Anemia	0 occurrences of toxicities	1 occurrences of toxicities	5 occurrences of toxicities	4 occurrences of toxicities	9 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Febrile neutropenia	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Lymphocyte count decreased	0 occurrences of toxicities	0 occurrences of toxicities	3 occurrences of toxicities	3 occurrences of toxicities	13 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Neutrophil count decreased	0 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	6 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Platelet count decreased	1 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	2 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Vomiting	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 Weight loss	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 3 White cell count decreased	1 occurrences of toxicities	1 occurrences of toxicities	3 occurrences of toxicities	3 occurrences of toxicities	4 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 4 Lymphocyte count decreased	1 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 4 Neutrophil count decreased	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	4 occurrences of toxicities	5 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 4 Platelet count decreased	1 occurrences of toxicities	0 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	1 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 4 White blood cell count decreased	0 occurrences of toxicities	0 occurrences of toxicities	2 occurrences of toxicities	2 occurrences of toxicities	3 occurrences of toxicities	—	—	—
Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts Grade 5 Any toxicity	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	0 occurrences of toxicities	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI); and Cycle 6 Day 1.

Population: 24/45 participants were analyzed because pharmacokinetics for phase II was not collected. These were not collected for Ph II as they were in the study calendar of the protocol for Phase I. This outcome was only calculated for phase I solid tumors. 2/3 participants were analyzed in solid tumor dose level 1 because one participant was omitted due to incomplete serial PK collection.

Blood samples for pharmacokinetic (PK) analysis were collected at pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI. Samples were drawn into sodium heparin tubes, processed to plasma, and stored at -80°C. On Cycle 6 Day 1 (C6D1), additional samples were collected to evaluate EP0057 (CLRX101) accumulation and potential drug interactions. Total plasma concentrations of released camptothecin (CPT) were measured after acidification with 0.1 normality (N) hydrochloric acid (HCl) to stabilize the lactone form, followed by dilution and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry, (UPLC-MS/MS) analysis. Noncompartmental analysis was used to calculate PK parameters. Concentrations below lower limit of quantification (LLOQ) was excluded. Maximum serum concentration (CMAX) values were recorded as observed.

Outcome measures

Outcome measures
Measure	All Participants n=2 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=5 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib EP0057 Total Drug	6191.2 Ng/mL Standard Deviation 354.01	5641.1 Ng/mL Standard Deviation 682.36	5307.0 Ng/mL Standard Deviation 475.81	4998.4 Ng/mL Standard Deviation 538.03	5844.9 Ng/mL Standard Deviation 797.76	—	—	—
Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib EP0057 Released Camptothecin	403.61 Ng/mL Standard Deviation 63.307	355.14 Ng/mL Standard Deviation 116.03	332.24 Ng/mL Standard Deviation 76.841	168.03 Ng/mL Standard Deviation 82.751	205.10 Ng/mL Standard Deviation 59.736	—	—	—
Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib Olaparib	2843.0 Ng/mL Standard Deviation 947.62	1773.9 Ng/mL Standard Deviation 1548.0	4729.8 Ng/mL Standard Deviation 2375.2	5238.6 Ng/mL Standard Deviation 4132.4	5445.7 Ng/mL Standard Deviation 4865.5	—	—	—

SECONDARY outcome

Timeframe: Baseline, Cycle 1, then every 2 cycles, and at progression

Drug concentrations in tissue specimens.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 1, then every 2 cycles, and at progression

Population: Data was collected for 4 participants but not analyzed. We will never submit results because PD evaluation cannot be performed on baseline biopsies. Pharmacodynamic studies aim to assess the biological effects of a drug on its target or pathway within the tissue after administration. Baseline biopsies, collected prior to any treatment, reflect the untreated state of the tissue and therefore do not provide information on drug-induced changes or target modulation.

Drug concentrations in tumor specimens.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants with solid tumors who received at least one dose of the study drug will be evaluable.	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=5 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 Participants "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 Participants "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=13 Participants "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=4 Participants "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg n=4 Participants "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	3 Participants	5 Participants	3 Participants	6 Participants	7 Participants	13 Participants	4 Participants	4 Participants

Adverse Events

Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 5 deaths

Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth)

Serious events: 6 serious events

Other events: 6 other events

Deaths: 6 deaths

Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 7 deaths

Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth)

Serious events: 6 serious events

Other events: 13 other events

Deaths: 11 deaths

Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) n=3 participants at risk "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=5 participants at risk "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 participants at risk "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 participants at risk "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 participants at risk "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=13 participants at risk "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=4 participants at risk "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg n=4 participants at risk "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Blood bilirubin increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Creatinine increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Death NOS	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Fatigue	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Hepatic infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify: Biliary obstruction	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Hypotension	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Infections and infestations - Other, specify: C diff	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Lung infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Cardiac disorders Mobitz (type) II atrioventricular block	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Nausea	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Nervous system disorders - Other, specify: Left lower extremity numbness	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Nervous system disorders - Other, specify: Word finding difficulty	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Neutrophil count decreased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Cardiac disorders Pericardial effusion	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Presyncope	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Sepsis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Redness of mediport area	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Stroke	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Superior vena cava syndrome	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Thromboembolic event	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Urinary tract infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations White blood cell decreased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.

Other adverse events

Other adverse events
Measure	Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) n=3 participants at risk "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) n=5 participants at risk "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) n=3 participants at risk "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) n=6 participants at risk "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) n=7 participants at risk "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=13 participants at risk "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) n=4 participants at risk "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."	Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg n=4 participants at risk "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m\^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles."
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 3/6 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Activated partial thromboplastin time prolonged	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 3/6 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Psychiatric disorders Agitation	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	71.4% 5/7 • Number of events 8 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Alkaline phosphatase increased	100.0% 3/3 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 4/6 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 7/7 • Number of events 18 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Alkalosis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Immune system disorders Allergic reaction	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	60.0% 3/5 • Number of events 15 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 17 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	83.3% 5/6 • Number of events 11 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	85.7% 6/7 • Number of events 43 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	46.2% 6/13 • Number of events 19 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	75.0% 3/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 9 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Psychiatric disorders Anxiety	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Ascites	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	71.4% 5/7 • Number of events 9 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Bloating	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Blood bilirubin increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Eye disorders Blurred vision	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Injury, poisoning and procedural complications Bruising	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations CPK increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Cardiac disorders Chest pain - cardiac	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Chills	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Psychiatric disorders Confusion	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 3/3 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	53.8% 7/13 • Number of events 8 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Creatinine increased	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	40.0% 2/5 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 3/6 • Number of events 8 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	75.0% 3/4 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Psychiatric disorders Delirium	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	38.5% 5/13 • Number of events 9 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Dizziness	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Eye disorders Dry eye	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Dysarthria	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Dysgeusia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Edema face	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	40.0% 2/5 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 3/6 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	71.4% 5/7 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	76.9% 10/13 • Number of events 10 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Fever	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Flushing	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations GGT increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Black stool	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders General disorders and administration site conditions - Other, specify: Disease progression	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders General disorders and administration site conditions - Other, specify: Night sweats	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Psychiatric disorders Hallucinations	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Headache	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Ear and labyrinth disorders Hearing impaired	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Hematuria	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Hemorrhoids	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	40.0% 2/5 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Hypertension	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	60.0% 3/5 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	83.3% 5/6 • Number of events 16 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 7/7 • Number of events 17 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	40.0% 2/5 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	60.0% 3/5 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypomagnesemia	66.7% 2/3 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	40.0% 2/5 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 3/6 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	38.5% 5/13 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Hypotension	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Infections and infestations - Other, specify: C diff	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Infections and infestations - Other, specify: oral candidiasis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Infusion related reaction	66.7% 2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Infusion site extravasation	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Psychiatric disorders Insomnia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Lipase increased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Localized edema	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Lung infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Lymphocyte count decreased	100.0% 3/3 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 5/5 • Number of events 19 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 3/3 • Number of events 12 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 6/6 • Number of events 26 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	71.4% 5/7 • Number of events 42 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	38.5% 5/13 • Number of events 17 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Cardiac disorders Mobitz (type) II atrioventricular block	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Mucosal infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Cramping in L hand	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Nail discoloration	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Nausea	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 9 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	38.5% 5/13 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	75.0% 3/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Nervous system disorders - Other, specify: Muscle jerks	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 3/3 • Number of events 10 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	83.3% 5/6 • Number of events 18 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 14 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Eye disorders Optic nerve disorder	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
General disorders Pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Papulopustular rash	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Paresthesia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 8 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	83.3% 5/6 • Number of events 17 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	71.4% 5/7 • Number of events 19 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 8 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Proteinuria	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	15.4% 2/13 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Urine output decreased	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Rhinitis infective	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Sinusitis	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Rash: b/l LLE- no itching, not painful.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Rash: rt shoulder, dry skin.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Redness	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Syncope	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Vascular disorders Thromboembolic event	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	28.6% 2/7 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Nervous system disorders Tremor	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	33.3% 1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Upper respiratory infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Urinary retention	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	50.0% 2/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Urinary tract infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	30.8% 4/13 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Urinary tract pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Renal and urinary disorders Urinary urgency	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Infections and infestations Vaginal infection	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Reproductive system and breast disorders Vaginal pain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	20.0% 1/5 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	66.7% 2/3 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	57.1% 4/7 • Number of events 5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Weight gain	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations Weight loss	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	16.7% 1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	42.9% 3/7 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/13 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/5 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/3 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	14.3% 1/7 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	7.7% 1/13 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Investigations White blood cell decreased	33.3% 1/3 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	60.0% 3/5 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	100.0% 3/3 • Number of events 21 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	83.3% 5/6 • Number of events 16 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	71.4% 5/7 • Number of events 28 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	23.1% 3/13 • Number of events 11 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	0.00% 0/4 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.

Additional Information

Dr. Anish Thomas

National Cancer Institute

Phone: 240-760-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place