Trial Outcomes & Findings for A Study of ONO-7475 in Patients With Acute Leukemias (NCT NCT03176277)

Last Updated: 2024-07-15

Results Overview

Incidence of most common (frequency of \>20%) treatment-emergent adverse events (TEAEs) of CTCAE grade 3 or higher by preferred terms coded with MedDRA version 23.1. CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

42 participants

Primary outcome timeframe

From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

Results posted on

2024-07-15

Participant Flow

Part A study: a total of 29 participants signed informed consent form and were enrolled in the study. 9 participants were screen failures who did not meet eligibility criteria. 20 participants received at least 1 dose of study drug. Part D study: a total of 33 participants signed informed consent form and were enrolled in the study. 11 participants were screen failures who did not meet eligibility criteria. 22 participants received at least 1 dose of study drug. No dose escalation conducted.

Participant milestones

Participant milestones
Measure	ONO-7475 3mg Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10mg Part A 3rd dose level	ONO-7475 6mg + Venetoclax Part D combination ONO-7475 + Venetoclax
Part A Dose Escalation Study STARTED	10	3	7	0
Part A Dose Escalation Study COMPLETED	0	0	0	0
Part A Dose Escalation Study NOT COMPLETED	10	3	7	0
Part D ONO-7475 6mg + Venetoclax STARTED	0	0	0	22
Part D ONO-7475 6mg + Venetoclax COMPLETED	0	0	0	22
Part D ONO-7475 6mg + Venetoclax NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ONO-7475 3mg Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10mg Part A 3rd dose level
Part A Dose Escalation Study Adverse Event	1	0	1
Part A Dose Escalation Study Physician Decision	1	1	2
Part A Dose Escalation Study Withdrawal by Subject	5	1	1
Part A Dose Escalation Study Progressive disease	3	1	3

Baseline Characteristics

This data was not captured for Part D ONO-7475 6mg + venetoclax

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10mg n=7 Participants Part A 3rd dose level	ONO-7475 6mg + Venetoclax n=22 Participants Part D combination of ONO-7475 + Venetoclax	Total n=42 Participants Total of all reporting groups
Age, Continuous Age	56.0 years n=10 Participants	65.0 years n=3 Participants	72.0 years n=7 Participants	65.5 years n=22 Participants	67.0 years n=42 Participants
Age, Customized <=60 years	5 Participants n=10 Participants	1 Participants n=3 Participants	0 Participants n=7 Participants	9 Participants n=22 Participants	15 Participants n=42 Participants
Age, Customized >60 years	5 Participants n=10 Participants	2 Participants n=3 Participants	7 Participants n=7 Participants	13 Participants n=22 Participants	27 Participants n=42 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	3 Participants n=3 Participants	4 Participants n=7 Participants	9 Participants n=22 Participants	22 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	0 Participants n=3 Participants	3 Participants n=7 Participants	13 Participants n=22 Participants	20 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	2 Participants n=22 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=10 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants	20 Participants n=22 Participants	39 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	3 Participants n=10 Participants	1 Participants n=3 Participants	1 Participants n=7 Participants	4 Participants n=22 Participants	9 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=10 Participants	2 Participants n=3 Participants	5 Participants n=7 Participants	15 Participants n=22 Participants	27 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	3 Participants n=22 Participants	5 Participants n=42 Participants
Region of Enrollment United States	10 participants n=10 Participants	3 participants n=3 Participants	7 participants n=7 Participants	22 participants n=22 Participants	42 participants n=42 Participants
ECOG performance status Grade 0	2 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	1 Participants n=22 Participants	4 Participants n=42 Participants
ECOG performance status Grade 1	7 Participants n=10 Participants	2 Participants n=3 Participants	4 Participants n=7 Participants	19 Participants n=22 Participants	32 Participants n=42 Participants
ECOG performance status Grade 2	1 Participants n=10 Participants	1 Participants n=3 Participants	2 Participants n=7 Participants	2 Participants n=22 Participants	6 Participants n=42 Participants
Height	158.0 Centimeter n=10 Participants	160.0 Centimeter n=3 Participants	163.0 Centimeter n=7 Participants	168 Centimeter n=22 Participants	165 Centimeter n=42 Participants
Weight	76.30 Kilogram n=10 Participants	82.50 Kilogram n=3 Participants	64.10 Kilogram n=7 Participants	75.45 Kilogram n=22 Participants	74.25 Kilogram n=42 Participants
BMI	29.25 Kilogram per square meter n=10 Participants	32.22 Kilogram per square meter n=3 Participants	25.54 Kilogram per square meter n=7 Participants	24.03 Kilogram per square meter n=22 Participants	25.56 Kilogram per square meter n=42 Participants
AML FAB classification at initial diagnosis M1 - ACUTE MYELOBLASTIC LEUKEMIA WITH MINIMAL MATURATION	1 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	1 Participants n=22 Participants	3 Participants n=42 Participants
AML FAB classification at initial diagnosis M2 - ACUTE MYELOBLASTIC LEUKEMIA WITH MATURATION	3 Participants n=10 Participants	1 Participants n=3 Participants	1 Participants n=7 Participants	4 Participants n=22 Participants	9 Participants n=42 Participants
AML FAB classification at initial diagnosis M5 - ACUTE MONOCYTIC LEUKEMIA	1 Participants n=10 Participants	1 Participants n=3 Participants	1 Participants n=7 Participants	0 Participants n=22 Participants	3 Participants n=42 Participants
AML FAB classification at initial diagnosis M7 - ACUTE MEGAKARYOBLASTIC LEUKEMIA	0 Participants n=10 Participants	1 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	2 Participants n=42 Participants
AML FAB classification at initial diagnosis UNKNOWN	4 Participants n=10 Participants	0 Participants n=3 Participants	4 Participants n=7 Participants	8 Participants n=22 Participants	16 Participants n=42 Participants
AML FAB classification at initial diagnosis MISSING	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
AML FAB classification at initial diagnosis Acute Myeloid Leukaemia With Cup Like Morphology	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	1 Participants n=42 Participants
AML FAB classification at initial diagnosis M0 - Undifferentiated Acute Myeloblastic Leukemia	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	5 Participants n=22 Participants	5 Participants n=42 Participants
AML FAB classification at initial diagnosis M4 - Acute Myelomonocytic Leukemia	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	2 Participants n=22 Participants	2 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification ACUTE MEGAKARYOBLASTIC LEUKEMIA	0 Participants n=10 Participants	1 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	2 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification ACUTE MONOBLASTIC/MONOCYTIC LEUKEMIA	0 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification ACUTE MYELOID LEUKEMIA WITH MYELODYSPLASIA-RELATED CHANGES	3 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	9 Participants n=22 Participants	13 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification ACUTE MYELOMONOCYTIC LEUKEMIA	0 Participants n=10 Participants	1 Participants n=3 Participants	0 Participants n=7 Participants	2 Participants n=22 Participants	3 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification AML WITH INV(16)(P13.1Q22) OR T(16;16)(P13.1;Q22); CBFB-MYH11	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification AML WITH MATURATION	2 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	3 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification AML WITH MINIMAL DIFFERENTIATION	1 Participants n=10 Participants	0 Participants n=3 Participants	2 Participants n=7 Participants	0 Participants n=22 Participants	3 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification AML WITH MUTATED RUNX1	0 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	2 Participants n=22 Participants	3 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification AML, NOS	1 Participants n=10 Participants	1 Participants n=3 Participants	1 Participants n=7 Participants	5 Participants n=22 Participants	8 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification UNKNOWN	2 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	1 Participants n=22 Participants	4 Participants n=42 Participants
AML classification at initial diagnosis 2008 2016 revisions to 2008 WHO classification AML Without Maturation	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	1 Participants n=42 Participants
Extramedullary involvement at diagnosis No	9 Participants n=10 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants	19 Participants n=22 Participants	38 Participants n=42 Participants
Extramedullary involvement at diagnosis Unknown	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	3 Participants n=22 Participants	4 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening ACUTE MEGAKARYOBLASTIC LEUKEMIA	0 Participants n=10 Participants	1 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	2 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening ACUTE MYELOBLASTIC/MONOCYTIC LEUKEMIA	0 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening ACUTE MYELOID LEUKEMIA WITH MYELODYSPLASIA-RELATED CHANGES	5 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	6 Participants n=22 Participants	11 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening ACUTE MYELOMONOCYTIC LEUKEMIA	0 Participants n=10 Participants	1 Participants n=3 Participants	0 Participants n=7 Participants	2 Participants n=22 Participants	3 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening AML WITH INV(16)(P13.1Q22) OR T(16;16)(P13.1;Q22); CBFB-MYH11	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening AML WITH MATURATION	2 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=22 Participants	3 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening AML WITH MINIMAL DIFFERENTIATION	1 Participants n=10 Participants	0 Participants n=3 Participants	3 Participants n=7 Participants	0 Participants n=22 Participants	4 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening AML WITH MUTATED RUNX1	0 Participants n=10 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	3 Participants n=22 Participants	4 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening AML, NOS	1 Participants n=10 Participants	1 Participants n=3 Participants	2 Participants n=7 Participants	7 Participants n=22 Participants	11 Participants n=42 Participants
AML classification performed according to WHO criteria 2016 completed at screening AML With Recurrent Genetic Abnormalities	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	2 Participants n=22 Participants	2 Participants n=42 Participants
Extramedullary involvement at present No	9 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	22 Participants n=22 Participants	31 Participants n=42 Participants
Extramedullary involvement at present Unknown	1 Participants n=10 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants	0 Participants n=22 Participants	11 Participants n=42 Participants
Extramedullary involvement at present Yes	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	0 Participants n=42 Participants
Current AML status De novo	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
Current AML status Refractory	6 Participants n=10 Participants	3 Participants n=3 Participants	5 Participants n=7 Participants	9 Participants n=22 Participants	23 Participants n=42 Participants
Current AML status Relapsed	3 Participants n=10 Participants	0 Participants n=3 Participants	2 Participants n=7 Participants	13 Participants n=22 Participants	18 Participants n=42 Participants
Immunophenotyping results available CD34+	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
Immunophenotyping results available Other	8 Participants n=10 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants	17 Participants n=22 Participants	35 Participants n=42 Participants
Immunophenotyping results available Missing	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	5 Participants n=22 Participants	6 Participants n=42 Participants
HLA-DR results available Positive	9 Participants n=10 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants	18 Participants n=22 Participants	37 Participants n=42 Participants
HLA-DR results available Negative	1 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=22 Participants	1 Participants n=42 Participants
HLA-DR results available Missing	0 Participants n=10 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	4 Participants n=22 Participants	4 Participants n=42 Participants
HLA-DR risk group Favorable	1 Participants n=10 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants n=3 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants n=7 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants This data was not captured for Part D ONO-7475 6mg + venetoclax	1 Participants n=20 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax
HLA-DR risk group Intermediate	2 Participants n=10 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants n=3 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	1 Participants n=7 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants This data was not captured for Part D ONO-7475 6mg + venetoclax	3 Participants n=20 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax
HLA-DR risk group Adverse	6 Participants n=10 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	3 Participants n=3 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	6 Participants n=7 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants This data was not captured for Part D ONO-7475 6mg + venetoclax	15 Participants n=20 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax
HLA-DR risk group Missing	1 Participants n=10 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants n=3 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants n=7 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax	0 Participants This data was not captured for Part D ONO-7475 6mg + venetoclax	1 Participants n=20 Participants • This data was not captured for Part D ONO-7475 6mg + venetoclax
Left ventricular ejection fraction (LVEF)	57.0 Percent n=10 Participants	62.0 Percent n=3 Participants	61.0 Percent n=7 Participants	60.0 Percent n=22 Participants	60.0 Percent n=42 Participants
Time from initial diagnosis to first dose of ONO-7475	24.3 Months n=10 Participants	17.7 Months n=3 Participants	12.2 Months n=7 Participants	12.1 Months n=22 Participants	14.7 Months n=42 Participants

PRIMARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Incidence of Adverse Events (Part A) Anaemia	4 Participants	1 Participants	2 Participants	7 Participants
Incidence of Adverse Events (Part A) Febrile neutropenia	2 Participants	1 Participants	4 Participants	7 Participants
Incidence of Adverse Events (Part A) Pneumonia	4 Participants	1 Participants	0 Participants	5 Participants

PRIMARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475.

Incidence (frequency ≥ 2 participants) of serious treatment-emergent adverse events (all CTCAE grades) by preferred terms coded with MedDRA version 23.1. CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Incidence of Serious Adverse Events (Part A) Pneumonia	3 Participants	1 Participants	0 Participants	4 Participants
Incidence of Serious Adverse Events (Part A) Sepsis	3 Participants	1 Participants	0 Participants	4 Participants
Incidence of Serious Adverse Events (Part A) Febrile neutropenia	2 Participants	1 Participants	4 Participants	7 Participants
Incidence of Serious Adverse Events (Part A) Klebsiella bacteraemia	2 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475.

Incidence (all participants) of ophthalmological treatment-emergent adverse events (all CTCAE grades) by preferred terms coded with MedDRA Version 23.1. CTCAE = Common Terminology Criteria for Adverse Event version 4.03.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Cataract cortical	0 Participants	0 Participants	1 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Conjunctival haemorrhage	0 Participants	0 Participants	1 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Eyelid ptosis	1 Participants	0 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Night blindness	1 Participants	0 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Retinal aneurysm	0 Participants	1 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Retinal thickening	1 Participants	0 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Retinopathy	1 Participants	0 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Scleral haemorrhage	0 Participants	1 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Vision blurred	1 Participants	0 Participants	0 Participants	1 Participants
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A) Vitreous floaters	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475.

Participants with clinically significant changes in 12-lead Electrocardiogram (ECG) parameters.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Clinically Significant Changes in 12-Lead Electrocardiogram Parameters (Part A) Participants without clinically significant changes in 12-lead ECG parameters	10 Participants	3 Participants	7 Participants	20 Participants
Clinically Significant Changes in 12-Lead Electrocardiogram Parameters (Part A) Participants with clinically significant changes in 12-lead ECG parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475 and/or venetoclax.

Incidence of most common (frequency \> 20%) treatment-emergent adverse events (TEAEs) of CTCAE grade 3 or higher by preferred term coded with MedDRA version 23.1. CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Incidence of Adverse Events (Part D) Febrile neutropenia	7 Participants	—	—	—
Incidence of Adverse Events (Part D) Anaemia	5 Participants	—	—	—
Incidence of Adverse Events (Part D) Thrombocytopenia	5 Participants	—	—	—

PRIMARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475 and/or venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Incidence of Serious Adverse Events (Part D) Sepsis	3 Participants	—	—	—
Incidence of Serious Adverse Events (Part D) Febrile neutropenia	7 Participants	—	—	—
Incidence of Serious Adverse Events (Part D) Gastrointestinal haemorrhage	2 Participants	—	—	—

PRIMARY outcome

Timeframe: From baseline up to maximum of 21 months

Population: Full analysis set

Summary of complete response (CR) and complete response with partial hematologic recovery (CRh) rate.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Complete Response (CR) / Complete Response With Partial Hematologic Recovery (CRh) Rate (Part D) Complete remission	0 Participants	—	—	—
Complete Response (CR) / Complete Response With Partial Hematologic Recovery (CRh) Rate (Part D) Complete response with partial hematologic recovery	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 28 days

Population: Analysis set included participants evaluable for DLT, defined as participants received ONO-7475 with a minimum dose intensity of 75% within DLT evaluation period \[from first dose to Day 28\] and had completed Day 28 assessments.

Dose Limiting Toxicities (DLT) Criteria: 1) ONO-7475-related ≥Grade 4 hematologic toxicity, 2) any pre-existing condition that worsens by more than 1 grade or to Grade 4, not caused by AML, 3) any ≥Grade 3 non-hematologic toxicity not caused by AML (exception: alopecia, nausea, vomiting, fatigue, headache, chills, electrolyte disturbances), 4) ≥Grade 2 blurred vision (confirmed by loss of 15 letters or more on Early Treatment Diabetic Retinopathy chart and by ophthalmological and retinal assessments) not caused by AML, 5) ≥Grade 2 clinically significant changes in night blindness not caused by AML, 6) ≥Grade 3 differentiation syndrome, 7) death not caused by AML, and 8) any other event determined by the Safety Review Committee for dosing stop. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was applied for toxicity grading.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Determination of Maximum Tolerated Dose (MTD) by Assessing Dose Limiting Toxicities (DLT) (Part A) Numbers of participants experienced DLT	0 Participants	0 Participants	0 Participants	0 Participants
Determination of Maximum Tolerated Dose (MTD) by Assessing Dose Limiting Toxicities (DLT) (Part A) Numbers of participants not experienced DLT	10 Participants	3 Participants	7 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1 and Day 28

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter resulted were summarised.

Part A Pharmacokinetics Cmax of ONO-7475 assessed on day 1 and day 28, and Ctrough of ONO-7475 assessed on day 28 (pre-dose).

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=7 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=6 Participants Part A 3rd dose level	Total Part A total
Pharmacokinetics (Cmax and Ctrough) of ONO-7475 (Part A) Cmax (ng/mL) day 1	90.8 ng/mL Standard Deviation 17.49	86 ng/mL	319.8 ng/mL Standard Deviation 73.99	—
Pharmacokinetics (Cmax and Ctrough) of ONO-7475 (Part A) Cmax (ng/mL) day 28	369.0 ng/mL	189.5 ng/mL Standard Deviation 96.87	1037 ng/mL Standard Deviation 229.58	—
Pharmacokinetics (Cmax and Ctrough) of ONO-7475 (Part A) Ctrough (ng/mL) day 28	192.7 ng/mL Standard Deviation 154.23	353.0 ng/mL Standard Deviation 347.89	588.4 ng/mL Standard Deviation 250.90	—

SECONDARY outcome

Timeframe: Day 1 and Day 28

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter resulted were summarised. Insufficient evaluable data available for day 28 Tmax values in 3 mg dose group.

Part A Pharmacokinetics Tmax of ONO-7475 assessed on day 1 and day 28.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=7 Participants Part A initial dose level	ONO-7475 6mg n=2 Participants Part A 2nd dose level	ONO-7475 10 mg n=6 Participants Part A 3rd dose level	Total Part A total
Pharmacokinetics (Tmax) of ONO-7475 (Part A) Tmax (h) day 1	3.5 Hour (h) Standard Deviation 2.18	5.6 Hour (h)	3.2 Hour (h) Standard Deviation 2.4	—
Pharmacokinetics (Tmax) of ONO-7475 (Part A) Tmax (h) day 28	—	1.5 Hour (h) Standard Deviation 2.12	4.3 Hour (h) Standard Deviation 3.22	—

SECONDARY outcome

Timeframe: Day 1 and Day 28

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter resulted were summarised.

Part A Pharmacokinetics (AUC0-10h) of ONO-7475 assessed on day 1 and day 28, (AUC0-24h) of ONO-7475 assessed on day 1.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=9 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total Part A total
Pharmacokinetics (AUC) of ONO-7475 (Part A) AUC(0-10h) (ng*h/mL) day 1	559.3 ng*h/mL Standard Deviation 247.66	649.3 ng*h/mL Standard Deviation 296.73	2086.2 ng*h/mL Standard Deviation 767.91	—
Pharmacokinetics (AUC) of ONO-7475 (Part A) AUC(0-10h) (ng*h/mL) day 28	2534 ng*h/mL	1124.9 ng*h/mL Standard Deviation 654.75	6202.5 ng*h/mL Standard Deviation 2406.09	—
Pharmacokinetics (AUC) of ONO-7475 (Part A) AUC(0-24h) (ng*h/mL) day 1	1358.4 ng*h/mL Standard Deviation 198.56	1506.9 ng*h/mL	4870.3 ng*h/mL Standard Deviation 1147.48	—

SECONDARY outcome

Timeframe: Day 1 and Day 28

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter resulted were summarised. T1/2 was not calculable due to insufficient evaluable data.

Part A Pharmacokinetics T1/2 of ONO-7475 assessed on day 1 and day 28. T1/2 was not calculable due to insufficient evaluable data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28 and Day 57

Population: Pharmacokinetic analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter results. Food effect was not evaluated in 3mg dose group. Tmax, T1/2 and Ctrough ratios were not calculable due to insufficient data.

Part A Pharmacokinetics (Cmax, Tmax, AUC, T1/2, Ctrough) of the food effect on ONO-7475 assessed as ratio of Day57/Day28 and comparing pharmacokinetic parameters from dosing under fasted and non-fasted conditions assessed in 6mg and 10mg dose groups.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg Part A initial dose level	ONO-7475 6mg n=1 Participants Part A 2nd dose level	ONO-7475 10 mg n=1 Participants Part A 3rd dose level	Total Part A total
Pharmacokinetics of the Food Effect on ONO-7475 (Part A) Day 57/Day 28 ratio of Cmax	—	0.89 ratio Interval 0.89 to 0.89	1.13 ratio Interval 1.13 to 1.13	—
Pharmacokinetics of the Food Effect on ONO-7475 (Part A) Day 57/Day 28 ratio of AUC (0-10h)	—	0.88 ratio Interval 0.88 to 0.88	1.69 ratio Interval 1.69 to 1.69	—

SECONDARY outcome

Timeframe: Day 2 and Day 28

Population: Pharmacodynamic (PD) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PD parameter results were summarised.

Assessment of the pharmacodynamic activity by measurement of Axl and Mer inhibition using a Plasma Inhibitory Activity (PIA) assay. PIA is a flow cytometry assay measuring auto-phosphorylation in Axl-expressing Ba/F3 and Mer-expressing Ba/F3 cells, respectively the percentage of inhibition. Pre-dose samples were collected for the analysis on day 2 and day 28.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=6 Participants Part A initial dose level	ONO-7475 6mg n=1 Participants Part A 2nd dose level	ONO-7475 10 mg n=5 Participants Part A 3rd dose level	Total Part A total
Pharmacodynamics (Axl and Mer Inhibition) of ONO-7475 (Part A) Axl %inhibition Day 2 Pre-dose	53.13 percentage Standard Deviation 20.971	19.10 percentage Standard Deviation NA SD not calculable	88.57 percentage Standard Deviation 4.876	—
Pharmacodynamics (Axl and Mer Inhibition) of ONO-7475 (Part A) Axl %Inhibition Day 28 Pre-Dose	82.50 percentage Standard Deviation 11.811	99.5 percentage Standard Deviation NA SD not calculable	90.30 percentage Standard Deviation 8.344	—
Pharmacodynamics (Axl and Mer Inhibition) of ONO-7475 (Part A) Mer %inhibition Day 2 Pre-dose	31.40 percentage Standard Deviation 9.475	—	55.78 percentage Standard Deviation 11.932	—
Pharmacodynamics (Axl and Mer Inhibition) of ONO-7475 (Part A) Mer %Inhibition Day 28 Pre-Dose	42.60 percentage Standard Deviation NA SD not calculable	69.1 percentage Standard Deviation NA SD not calculable	91.5 percentage Standard Deviation 10.209	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 32 months

Population: Full analysis set

Part A analysis of best overall response. Duration of response analysis was not performed as no response of complete remission, Morphologic complete remission with incomplete blood count recovery, morphologic leukemia-free state, or partial remission was observed.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A) Complete response	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A) Morphologic complete remission with incomplete blood count recovery	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A) Morphologic leukemia-free state	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A) Partial remission	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A) Treatment failure	5 Participants	3 Participants	5 Participants	13 Participants
Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A) Not evaluated / assessed	5 Participants	0 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: From baseline up to maximum of 32 months

Population: Full analysis set

Part A analysis of event free survival in ONO-7475 treatment groups

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=10 Participants Part A initial dose level	ONO-7475 6mg n=3 Participants Part A 2nd dose level	ONO-7475 10 mg n=7 Participants Part A 3rd dose level	Total n=20 Participants Part A total
Event Free Survival in ONO-7475 Groups (Part A)	1.0 Months Interval 0.3 to 1.3	0.9 Months Interval 0.9 to 1.6	0.9 Months Interval 0.9 to 1.6	1.0 Months Interval 0.9 to 1.1

SECONDARY outcome

Timeframe: Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter results.

Part D Pharmacokinetics (Cmax) of ONO-7475 in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=15 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (Cmax) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D)	622 ng/mL Standard Deviation 236	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter results.

Part D Pharmacokinetics (Tmax) of ONO-7475 in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=15 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (Tmax) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D)	5.58 Hour (h) Standard Deviation 5.84	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter results.

Part D Pharmacokinetics (AUC) of ONO-7475 in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=15 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (AUC) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D) AUC (0-10h) (ng*h/mL) of ONO-7475 Day 29	4810 ng*h/mL Standard Deviation 1990	—	—	—
Pharmacokinetics (AUC) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D) AUC (0-24h) (ng*h/mL) of ONO-7475 Day 29	11100 ng*h/mL Standard Deviation 4820	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter results. T1/2 of ONO-7475 was not calculable due to insufficient evaluable data.

Part D Pharmacokinetics (T1/2) of ONO-7475 in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 and Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of venetoclax and with evaluable PK parameter results.

Part D Pharmacokinetics (Cmax) of Venetoclax in treatment group ONO-7475 + Venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=17 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (Cmax) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D) Cmax (ng/mL) Day 1	310 ng/mL Standard Deviation 281	—	—	—
Pharmacokinetics (Cmax) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D) Cmax (ng/mL) Day 29	1870 ng/mL Standard Deviation 846	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of ONO-7475 and with evaluable PK parameter results.

Part D Pharmacokinetics (Tmax) of Venetoclax in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (Tmax) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D) Tmax day 1	6.72 Hour (h) Standard Deviation 1.99	—	—	—
Pharmacokinetics (Tmax) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D) Tmax day 29	7.07 Hour (h) Standard Deviation 4.85	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of venetoclax and with evaluable PK parameter results.

Part D Pharmacokinetics (AUC) of Venetoclax in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (AUC) of Venetoclax in Treatment Group ONO-7475 + Venetoclax AUC (0-10h) day 1	1330 ng*h/mL Standard Deviation 1220	—	—	—
Pharmacokinetics (AUC) of Venetoclax in Treatment Group ONO-7475 + Venetoclax AUC (0-10h) day 29	14700 ng*h/mL Standard Deviation 8650	—	—	—
Pharmacokinetics (AUC) of Venetoclax in Treatment Group ONO-7475 + Venetoclax AUC (0-24h) day day 29	32900 ng*h/mL Standard Deviation 19200	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: Pharmacokinetic (PK) analysis set, in participants who received at least 1 dose of Venetoclax and with evaluable PK parameter results.

Part D Pharmacokinetics (T1/2) of Venetoclax in treatment group ONO-7475 + venetoclax.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=1 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Pharmacokinetics (T1/2) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D)	5.8 Hour (h)	—	—	—

SECONDARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475 and/or venetoclax.

Part D Incidence (frequency \> 20%) and severity (CTCAE grades) of treatment-emergent adverse events in ONO-7475 + Venetoclax Group, in preferred terms coded MedDRA version 23.1. CTCAE = common terminology criteria for adverse events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg n=22 Participants Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Participants with treatment-emergent adverse events	21 Participants	20 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Fatigue	10 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Diarrhoea	7 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Febrile neutropenia	7 Participants	7 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Hypophosphataemia	7 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Anaemia	6 Participants	5 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Nausea	6 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Constipation	5 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Headache	5 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Hypokalaemia	5 Participants	0 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Thrombocytopenia	5 Participants	5 Participants	—	—
Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D) Vomiting	5 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

Population: Safety analysis set, in participants who received at least 1 dose of ONO-7475 and/or venetoclax

Part D Incidence (frequency ≥ 2 participants) and severity (CTCAE grades) of serious treatment-emergent adverse events in ONO-7475 + Venetoclax Group (Part D), preferred term coded with MedDRA version 23.1. CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg n=22 Participants Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Incidence of Serious Adverse Events in ONO-7475 + Venetoclax Group (Part D) Participants with serious adverse events	13 Participants	13 Participants	—	—
Incidence of Serious Adverse Events in ONO-7475 + Venetoclax Group (Part D) Sepsis	3 Participants	3 Participants	—	—
Incidence of Serious Adverse Events in ONO-7475 + Venetoclax Group (Part D) Febrile neutropenia	7 Participants	7 Participants	—	—
Incidence of Serious Adverse Events in ONO-7475 + Venetoclax Group (Part D) Gastrointestinal hemorrhage	2 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 21 months

Population: Full analysis set

Part D Summary of best overall response in ONO-7475 + Venetoclax group.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Overall Response Rate in ONO-7475 + Venetoclax Group (Part D) Complete remission	0 Participants	—	—	—
Overall Response Rate in ONO-7475 + Venetoclax Group (Part D) Complete remission with incomplete hematologic recovery	1 Participants	—	—	—
Overall Response Rate in ONO-7475 + Venetoclax Group (Part D) Morphologic leukemia free state	1 Participants	—	—	—
Overall Response Rate in ONO-7475 + Venetoclax Group (Part D) Partial remission	2 Participants	—	—	—
Overall Response Rate in ONO-7475 + Venetoclax Group (Part D) Treatment failure	16 Participants	—	—	—
Overall Response Rate in ONO-7475 + Venetoclax Group (Part D) Not evaluated / assessed	2 Participants	—	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 21 months

Population: Full analysis set. Participants with best response assessed as complete remission, complete remission with partial hematologic recovery, complete remission with incomplete hematologic recovery, morphologic leukemia free state and partial remission were included in analysis.

Part D Duration of response in ONO-7475 6mg + Venetoclax group.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=4 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Duration of Response in ONO-7475 + Venetoclax Group (Part D)	1.881 Months Standard Deviation 2.5073	—	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 21 months

Population: Full analysis set

Part D analysis of event free survival and overall survival in ONO-7475 6mg + Venetoclax group

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=22 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Event-Free Survival and Overall Survival in ONO-7475 + Venetoclax Group (Part D) Event free survival	0.99 Months Interval 0.95 to 1.9	—	—	—
Event-Free Survival and Overall Survival in ONO-7475 + Venetoclax Group (Part D) Overall survival	4.01 Months Interval 2.6 to 10.25	—	—	—

SECONDARY outcome

Timeframe: From baseline up to maximum of 21 months

Population: Full analysis set and in participants who were transfusion independent at baseline.

Part D analysis of transfusion Independence rate. Rate of maintenance of transfusion independence = percentage of patients who were transfusion independent post-baseline based upon the patients who were transfusion independent at baseline. Calculated using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	ONO-7475 3mg n=7 Participants Part A initial dose level	ONO-7475 6mg Part A 2nd dose level	ONO-7475 10 mg Part A 3rd dose level	Total Part A total
Transfusion Independence Rate (Part D)	87.5 percentage of participants Interval 47.3 to 99.7	—	—	—

Adverse Events

ONO-7475 3mg (Part A)

Serious events: 9 serious events

Other events: 10 other events

Deaths: 10 deaths

ONO-7475 6mg (Part A)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

ONO-7475 10mg (Part A)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 5 deaths

ONO-7475 6mg + Venetoclax (Part D)

Serious events: 13 serious events

Other events: 21 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Information Center

Ono Pharmaceutical Co., Ltd.

Phone: Please see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	ONO-7475 3mg (Part A) n=10 participants at risk Part A ONO-7475 initial dose level 3mg	ONO-7475 6mg (Part A) n=3 participants at risk Part ONO-7475 2nd dose level 6mg	ONO-7475 10mg (Part A) n=7 participants at risk Part A ONO-7475 3rd dose level 10mg	ONO-7475 6mg + Venetoclax (Part D) n=22 participants at risk Part D combination of ONO-7475 6mg + venetoclax
Infections and infestations Pneumonia	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Sepsis	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Klebsiella bacteraemia	20.0% 2/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Klebsiella sepsis	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Arthritis infective	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Bacteraemia	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Cellulitis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Influenza	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Pneumonia respiratory syncytial viral	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Respiratory syncytial virus bronchitis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Stenotrophomonas sepsis	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Streptococcal bacteraemia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations COVID-19	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Enterocolitis infectious	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Herpes simplex oesophagitis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Pneumonia bacterial	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Urinary tract infection	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 2/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	57.1% 4/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	31.8% 7/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Blood and lymphatic system disorders Disseminated intravascular coagulation	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Blood and lymphatic system disorders Pancytopenia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	9.1% 2/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Nausea	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Respiratory distress	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Nervous system disorders Syncope	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Multiple organ dysfunction syndrome	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	4.5% 1/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Cardiac disorders Cardiac failure congestive	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Investigations White blood cell count decreased	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hyperglycaemia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Differentiation syndrome	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Other adverse events
Measure	ONO-7475 3mg (Part A) n=10 participants at risk Part A ONO-7475 initial dose level 3mg	ONO-7475 6mg (Part A) n=3 participants at risk Part ONO-7475 2nd dose level 6mg	ONO-7475 10mg (Part A) n=7 participants at risk Part A ONO-7475 3rd dose level 10mg	ONO-7475 6mg + Venetoclax (Part D) n=22 participants at risk Part D combination of ONO-7475 6mg + venetoclax
Metabolism and nutrition disorders Hypokalaemia	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	57.1% 4/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	22.7% 5/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypomagnesaemia	40.0% 4/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	28.6% 2/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Decreased appetite	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	18.2% 4/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Dehydration	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hyperkalaemia	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypophosphataemia	20.0% 2/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	31.8% 7/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypocalcaemia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Fluid overload	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	9.1% 2/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypernatraemia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypoalbuminaemia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Hypovolaemia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Lactic acidosis	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Malnutrition	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Tumour lysis syndrome	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Diarrhoea	50.0% 5/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	28.6% 2/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	31.8% 7/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Vomiting	50.0% 5/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	28.6% 2/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	22.7% 5/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Nausea	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	28.6% 2/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	22.7% 5/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Abdominal pain	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Constipation	20.0% 2/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	22.7% 5/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Stomatitis	20.0% 2/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	9.1% 2/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Dental caries	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Dysphagia	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Flatulence	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Ileus	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Oral mucosa haematoma	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Poor dental condition	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Post-tussive vomiting	10.0% 1/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Umbilical hernia	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Toothache	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	9.1% 2/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Fatigue	30.0% 3/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	28.6% 2/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	45.5% 10/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Oedema peripheral	40.0% 4/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	66.7% 2/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Pyrexia	20.0% 2/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	28.6% 2/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	13.6% 3/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Asthenia	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	9.1% 2/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Chills	0.00% 0/10 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	33.3% 1/3 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	14.3% 1/7 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/22 • From an onset date on or after study drug start date and no later than 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum 32 months for Part A and 21 months for Part D). An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.