Trial Outcomes & Findings for Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer (NCT NCT04514497)

Last Updated: 2026-05-19

Results Overview

Defined by occurrence of \>= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting \>= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting \>= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade \>= 2 adverse events (AEs) lasting \>= 7 days (with the exception of grade 2 \[G2\] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

Up to 21 days (first treatment cycle)

Results posted on

2026-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	TAC 1 (Elimusertib, Irinotecan) Patients receive elimusertib 10 mg PO BID on days 1 and 2 and irinotecan 150 mg IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 2 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO BID on days 1 and 2 and irinotecan 150 mg IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 4 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 25 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Overall Study STARTED	6	3	6	6	2	6
Overall Study COMPLETED	6	2	6	2	1	6
Overall Study NOT COMPLETED	0	1	0	4	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TAC 2 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO BID on days 1 and 2 and irinotecan 150 mg IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Overall Study Adverse Event	1	2	0
Overall Study Withdrawal by Subject	0	2	0
Overall Study Death	0	0	1

Baseline Characteristics

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAC1 n=6 Participants TAC1: BAY1895344 10mg D1,2 + Irinotecan 150mg/m2 D1	TAC2 n=3 Participants TAC2: BAY1895344 20mg D1,2 + Irinotecan 150mg/m2 D1	TAC4 n=6 Participants TAC4: BAY 1895344 20 mg QD D2,3,9,10,16,17+Irinotecan 25 mg/m2 D1,8,15	TAC5 n=6 Participants TAC5: BAY 1895344 20 mg QD D2,3,9,10,16,17+Irinotecan 50 mg/m2 D1,8,15	TAC7 n=2 Participants TAC7: BAY1895344 20mg D2,5 + Topotecan 1mg/m2 D1-5	TAC14 n=6 Participants TAC14: BAY 1895344 20 mg QD D2,5+Topotecan 1 mg/m2 D1-5	Total n=29 Participants Total of all reporting groups
Age, Continuous	57.5 years n=30 Participants	69 years n=30 Participants	56 years n=60 Participants	56 years n=133 Participants	56 years n=21 Participants	65.5 years n=105 Participants	59 years n=99 Participants
Sex: Female, Male Female	5 Participants n=30 Participants	0 Participants n=30 Participants	3 Participants n=60 Participants	4 Participants n=133 Participants	1 Participants n=21 Participants	0 Participants n=105 Participants	13 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=30 Participants	3 Participants n=30 Participants	3 Participants n=60 Participants	2 Participants n=133 Participants	1 Participants n=21 Participants	6 Participants n=105 Participants	16 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	2 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=30 Participants	3 Participants n=30 Participants	6 Participants n=60 Participants	4 Participants n=133 Participants	2 Participants n=21 Participants	6 Participants n=105 Participants	27 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	3 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	1 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=21 Participants	1 Participants n=105 Participants	2 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	1 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=30 Participants	2 Participants n=30 Participants	4 Participants n=60 Participants	3 Participants n=133 Participants	2 Participants n=21 Participants	5 Participants n=105 Participants	22 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants	0 Participants n=99 Participants
Region of Enrollment United States	6 participants n=30 Participants	3 participants n=30 Participants	6 participants n=60 Participants	6 participants n=133 Participants	2 participants n=21 Participants	6 participants n=105 Participants	29 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 21 days (first treatment cycle)

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=9 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=12 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=8 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib	10 mg	20 mg	20 mg	—	—	—

PRIMARY outcome

Timeframe: Up to 21 days (first treatment cycle)

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=9 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=12 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan	150 mg/m^2	25 mg/m^2	—	—	—	—

PRIMARY outcome

Timeframe: Up to 21 days (first treatment cycle)

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=8 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan	1 mg/m^2	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 6 months post-treatment

Population: Study was terminated prior to enrolling patients into dose expansion.

Grade 4 hematologic toxicity will be monitored using the Bayesian approach of Thall, Simon, Estey as extended by Thall and Sung. Clinical safety data (e.g. AEs) will be tabulated and summarized using descriptive statistics as requested by the sponsor investigator, executive committee, medical monitor or Data Safety Monitoring Board using methods described in the Data Safety Monitoring Plan.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Tumor response was performed every 6 weeks during treatment and up to 6 months after completing treatment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) n=2 Participants Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Objective Response Rate (ORR)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.

Population: 0 participants in cohort TAC 7 had a complete response, partial response, or stable disease.

DOR will be estimated by the Kaplan-Meier method. Duration of response was calculated among patients with complete response, partial response, or stable disease.

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=4 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=1 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=4 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=2 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) n=3 Participants Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Duration of Response (DOR)	2.33 months Interval 0.23 to Upper 95% confidence interval not reached	1.43 months Both upper and lower 95% confidence intervals not reached	1.4 months Interval 1.03 to Upper 95% confidence interval not reached	1.45 months Interval 1.43 to Upper 95% confidence interval not reached	—	4.2 months Interval 3.13 to Upper 95% confidence interval not reached

SECONDARY outcome

Timeframe: Disease Progression was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.

PFS will be estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) n=2 Participants Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Progression-free Survival (PFS)	2.58 months Interval 1.37 to 5.53	1.4 months Interval 1.33 to Upper 95% confidence interval not reached	2.5 months Interval 1.53 to 2.8	2.03 months Interval 0.67 to 2.8	0.87 months Interval 0.47 to Upper 95% confidence interval not reached	3.28 months Interval 1.3 to 5.6

SECONDARY outcome

Timeframe: From date the participant starts treatment until the date of death from any cause, assessed up to 6 months following completion of treatment

OS will be estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) n=2 Participants Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Overall Survival (OS)	9.77 months Interval 4.97 to Upper 95% confidence interval not reached	2.93 months Interval 2.33 to Upper 95% confidence interval not reached	6.73 months Interval 3.87 to Upper 95% confidence interval not reached	4.47 months Interval 1.27 to 11.03	2.2 months Interval 0.47 to Upper 95% confidence interval not reached	9.4 months Interval 9.27 to Upper 95% confidence interval not reached

SECONDARY outcome

Timeframe: See above as time frames were different fore each dose cohort

Estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) n=2 Participants Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Maximum Concentration (Cmax) of Elimusertib	246 micrograms per liter Standard Deviation 1.53	526 micrograms per liter Standard Deviation 1.71	460 micrograms per liter Standard Deviation 1.53	492 micrograms per liter Standard Deviation 1.63	659 micrograms per liter Standard Deviation 1.19	247 micrograms per liter Standard Deviation 2.13

SECONDARY outcome

Timeframe: See above as time frames are different for each dose cohort

Will be estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) n=2 Participants Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Area Under the Concentration-time Curve (AUC) for Elimusertib	2.05 mg/L*h Standard Deviation 1.34	3.06 mg/L*h Standard Deviation 1.39	4.56 mg/L*h Standard Deviation 1.49	5.53 mg/L*h Standard Deviation 1.87	3.69 mg/L*h Standard Deviation 1.43	3.90 mg/L*h Standard Deviation 2.23

SECONDARY outcome

Timeframe: See above as time frames were different for each cohort

Estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Maximum Concentration (Cmax) of Irinotecan (Cohorts I and II)	1296 micrograms per liter Standard Deviation 1.12	1380 micrograms per liter Standard Deviation 1.35	230 micrograms per liter Standard Deviation 1.30	610 micrograms per liter Standard Deviation 1.78	—	—

SECONDARY outcome

Timeframe: See above as time frames were different for each cohort

Will be estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=3 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) n=6 Participants Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Area Under the Concentration-time Curve (AUC) for Irinotecan	7.29 mg/L*h Standard Deviation 1.13	7.93 mg/L*h Standard Deviation 1.31	1.18 mg/L*h Standard Deviation 1.29	3.79 mg/L*h Standard Deviation 1.30	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion

Estimated for topotecan based upon plasma collections from cycle 1 in all study patients.

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=2 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Maximum Concentration (Cmax) of Topotecan (Cohort III, TACs 7 and 14)	48.6 micrograms per liter Standard Deviation 1.08	35.4 micrograms per liter Standard Deviation 1.82	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1

Will be estimated for topotecan based upon plasma collections from cycle 1 in all study patients.

Outcome measures

Outcome measures
Measure	Cohort I (Elimusertib, Irinotecan) n=2 Participants Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort II (Elimusertib, Irinotecan) n=6 Participants Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	Cohort III (Elimusertib, Topotecan) Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 5 (Elimusertib, Irinotecan) Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC 7 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC 14 (Elimusertib, Topotecan) Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Area Under the Concentration-time Curve (AUC) for Topotecan	101 ug/L*h Standard Deviation 1.56	116 ug/L*h Standard Deviation 1.27	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to cycle 1, day 6

Population: Study was terminated prior to enrolling patients into dose expansion.

Will be estimated for expansion cohort only study patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to cycle 1, day 6

Population: Study was terminated prior to enrolling patients into dose expansion.

Will be estimated for expansion cohort only study patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Will assess the prevalence of tumor ATM expression loss in all patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ATM expression loss.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Will assess the specific tumor DDR gene mutations present in study patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumors with DDR gene mutations.

Outcome measures

Outcome data not reported

Adverse Events

TAC1 (10 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

TAC2 (20 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 3 deaths

TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

TAC7 (20 mg Elimusertib, 1 mg/m^2 Topotecan)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

TAC14 (20 mg Elimusertib, 1 mg/m^2 Topotecan)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	TAC1 (10 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan) n=6 participants at risk Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC2 (20 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan) n=3 participants at risk Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) n=6 participants at risk Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) n=6 participants at risk Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC7 (20 mg Elimusertib, 1 mg/m^2 Topotecan) n=2 participants at risk Patients receive elimusertib PO BID on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC14 (20 mg Elimusertib, 1 mg/m^2 Topotecan) n=6 participants at risk Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
General disorders Death	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Myocardial Infarction	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders Hypotension	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Neutrophil count decreased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations White Blood Cell Count Decreased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Fever	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Kidney Infection	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Gastric Outlet Obstruction	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Leukopenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Neutropenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders Thrombocytopenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Atrial Fibrillation	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Cardiac Arrest	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Pancytopenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.

Other adverse events

Other adverse events
Measure	TAC1 (10 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan) n=6 participants at risk Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC2 (20 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan) n=3 participants at risk Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) n=6 participants at risk Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) n=6 participants at risk Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI	TAC7 (20 mg Elimusertib, 1 mg/m^2 Topotecan) n=2 participants at risk Patients receive elimusertib PO BID on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV	TAC14 (20 mg Elimusertib, 1 mg/m^2 Topotecan) n=6 participants at risk Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV
Musculoskeletal and connective tissue disorders Abdominal Cramping	16.7% 1/6 • Number of events 10 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders Agitation	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Alanine Aminotransferase Increased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Alkaline Phosphatase increase	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders Alopecia	50.0% 3/6 • Number of events 32 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 8 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders fever	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Anemia	33.3% 2/6 • Number of events 22 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	100.0% 3/3 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 20 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 11 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 34 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders Anxiety	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Ascites	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 25 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Aspartate Aminotransferase	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations AST increase	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders BACK PAIN	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Hepatobiliary disorders Biliary Obstruction	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Bilirubin increased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Bloating	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 26 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Neutropenia	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 9 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Eye disorders Blurry Vision	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders Body Aches	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Chest Pain	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Chills	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders Confusion	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders COVID-19	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations creatinine increased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Decreased iron	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Decreased Lymphocyte Count	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 9 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders Delirium	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders depression	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Diaphoresis	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Diarrhea	66.7% 4/6 • Number of events 26 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	100.0% 3/3 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 4/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 11 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Diarrhea (pt describes as loose stool)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Diarrhea-Intermittent	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders Dizziness Intermittent	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders dry skin	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders Dysgeusia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Dysuria	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders early satiety	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Edema limbs	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 12 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Enteritis	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders Extrapyramidal disorder (restless leg syndrome)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Injury, poisoning and procedural complications FALL	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Fatigue	50.0% 3/6 • Number of events 18 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 4/6 • Number of events 18 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 4/6 • Number of events 28 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders Flushing (cheeks)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Gastroesophageal reflux disease	16.7% 1/6 • Number of events 15 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Hematuria	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Hemorrhoid	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders HOT FLASHES	16.7% 1/6 • Number of events 17 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders hyperglycemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 12 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders hypertension	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders hypoalbuminemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 11 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders hypocalcemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders hypomagnesemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders hypophosphatemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders hypotension	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Increased Alk Phos	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Increased ALT	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Increased AST	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Increased LDH	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Increased Total Bilirubin	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders Insomnia	33.3% 2/6 • Number of events 23 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 11 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders INTERMITTENT VOMITING	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders Jaw Mass	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Kidney infection	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Left Chest Pain (Non cardiac)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Left groin boil	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders Left Shoulder Skin Abscess	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders loss of appetite	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 8 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Low WBC	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Lung infection	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Lymphocyte Count Decrease	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 16 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Malaise	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Mouth Sores	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Mucositis	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Mucositis oral	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders MYALGIA	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Nausea	66.7% 4/6 • Number of events 22 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 9 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 4/6 • Number of events 20 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Neutrophil Count Decrease	33.3% 2/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 11 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 8 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Night sweats	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Nocturia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Non-cardiac chest pain'	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Oral mucositis	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Pain - R inguinal pain	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Pain (Left Arm)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Pain (right side pain)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders pain in extremity (right shoulder pain)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders Pain in Leg	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Palpitations	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Platelet Count Decreased	16.7% 1/6 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	100.0% 3/3 • Number of events 13 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	100.0% 2/2 • Number of events 8 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Platelet Count Decrease (Thrombocytopenia)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders port site erythema	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders presyncope	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Proteinuria	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders pruitis (legs)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders pruritis right middle back	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Pyuria	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders Rash Maculo-papular ash acneiform	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Psychiatric disorders Restlessness	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders right chest tenderness	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Injury, poisoning and procedural complications Sacral pressure wound	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Sepsis	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Musculoskeletal and connective tissue disorders Shoulder Pain	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Sinus Tachycardia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 1/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Sinusitis	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Weight Loss	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 11 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Skin and subcutaneous tissue disorders skin and subcutaneous tissue disorders other - right index finder laceration	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Nervous system disorders Somnolence	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Respiratory, thoracic and mediastinal disorders Tachypneic	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 3/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Thrush	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations troponin elevated	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 7 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Upper respiratory Infection	16.7% 1/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Renal and urinary disorders Urinary Frequency	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Infections and infestations Urinary tract infection	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Eye disorders Vitreous Hemorrhage	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Cardiac disorders Volume Overload	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	50.0% 1/2 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	100.0% 2/2 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations White blood cell count decreased	33.3% 2/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	66.7% 2/3 • Number of events 5 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	100.0% 2/2 • Number of events 2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	33.3% 2/6 • Number of events 3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations White Blood Cell Decrease (Intermittent)	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 8 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders Worsening anemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Metabolism and nutrition disorders worsening anorexia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Gastrointestinal disorders Worsening Constipation	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
General disorders Worsening Fatigue	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Blood and lymphatic system disorders worsening historic anemia	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 12 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Vascular disorders worsening Hypertension	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 4 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations worsening weight loss	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
Investigations Worsening white blood cell decreased	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/3 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	16.7% 1/6 • Number of events 1 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/2 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.	0.00% 0/6 • During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant All patients that received at least one dose of protocol prescribed treatment are included in this analysis.

Additional Information

Thatcher Heumann, MD, MPH

Vanderbilt University Medical Center

Phone: 615-936-8422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60