Trial Outcomes & Findings for A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT NCT02760485)

NCT ID: NCT02760485

Last Updated: 2023-06-15

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 30 days after the last dose of study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: up to 285 days
• Results posted on: 2023-06-15

Participant Flow

This study was conducted at 12 study centers in the United States.

Participant milestones

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 1 STARTED	7	7	0
Phase 1 COMPLETED	0	0	0
Phase 1 NOT COMPLETED	7	7	0
Phase 2 STARTED	0	0	19
Phase 2 COMPLETED	0	0	0
Phase 2 NOT COMPLETED	0	0	19

Reasons for withdrawal

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 1 Death	3	6	0
Phase 1 Withdrawal by Subject	2	0	0
Phase 1 Progressive Disease	1	0	0
Phase 1 Amendment Removed Survival Follow-up	0	1	0
Phase 1 Unknown; Did Not Complete End-of-Study Visit	1	0	0
Phase 2 Death	0	0	12
Phase 2 Withdrawal by Subject	0	0	3
Phase 2 Progressive Disease	0	0	1
Phase 2 Unknown; Did Not Complete End-of-Study Visit	0	0	3

Baseline Characteristics

A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 Participants Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=7 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=19 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Total n=32 Participants Total of all reporting groups
Race/Ethnicity, Customized White/Caucasian	6 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Black/African-American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	70.3 years STANDARD_DEVIATION 10.42 • n=5 Participants	67.0 years STANDARD_DEVIATION 13.39 • n=7 Participants	72.1 years STANDARD_DEVIATION 14.25 • n=5 Participants	70.6 years STANDARD_DEVIATION 13.20 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Captured as "Other"	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 285 days

Population: Safety Run-In Population: all participants enrolled in the Phase 1 portion of the study who received at least 1 dose of study drug

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 30 days after the last dose of study drug.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 Participants Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=7 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	6 Participants	7 Participants	—

PRIMARY outcome

Timeframe: up to 285 days

Population: Safety Run-In Population

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 30 days after the last dose of study drug. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 Participants Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=7 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 1: Number of Participants With Any Grade 3 or Higher TEAE	5 Participants	5 Participants	—

PRIMARY outcome

Timeframe: up to Day 28

Population: Safety Run-In Population

A DLT was defined as the occurrence of any protocol-defined toxicities occurring up to and including Study Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria. In order to be included in the tolerability review, subjects must have received the cohort-specific dose of INCB039110 and ibrutinib for at least 75% of the days during the 28-day surveillance period or have experienced a DLT.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 Participants Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=7 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: up to 1538 days

Population: Intent-to-Treat (ITT) Population: all participants enrolled in the Phase 2 portion of the study. The confidence interval was calculated based on the exact method for binomial distribution.

CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 centimeters (cm) in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; if lesion is too small to measure on computed tomography, assign 5 millimeters (mm) × 5 mm as default; if no longer visible, 0 mm × 0 mm. For node >5 mm × 5 mm but smaller than normal, use actual measurement; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=19 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 2: Objective Response Rate (ORR), Defined as the Percentage of Participants Achieving Either a Complete Response (CR) or a Partial Response (PR), Per the Modified Lugano Classification for Diffuse Large B-cell Lymphoma (DLBCL)	—	—	26.3 percentage of participants Interval 10.99 to 47.58

SECONDARY outcome

Timeframe: up to 250 days

Population: Safety Run-in Population. The confidence interval was calculated based on the exact method for binomial distribution.

CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the LDi; (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; if lesion is too small to measure on computed tomography, assign 5 mm × 5 mm as default; if no longer visible, 0 mm × 0 mm. For node >5 mm × 5 mm but smaller than normal, use actual measurement; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 Participants Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=7 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 1: ORR, Defined as the Percentage of Participants Achieving Either a CR or a PR, Per the Modified Lugano Classification for DLBCL	33.3 percentage of participants Interval 6.28 to 72.87	57.1 percentage of participants Interval 22.53 to 87.12	—

SECONDARY outcome

Timeframe: up to 947 days

Population: ITT Population. Participants who achieved a CR or a PR per Lugano Classification for DLBCL were analyzed. The 90% confidence interval was calculated using the Brookmeyer and Crowley's method.

Disease progression requires ≥1 of the following: (1) an abnormal individual node/lesion with all of the following: (a) LDi > 1.5 cm; (b) increase by ≥50% from cross product of the LDi and the perpendicular diameter (PPD) nadir; (c) increase in LDi or the shortest axis perpendicular to the LDi (SDi) from nadir: (i) 0.5 cm for lesions ≤2 cm; (ii) 1.0 cm for lesions > 2 cm. (2) For splenomegaly, the splenic length must increased by 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, must increase by at least 2 cm from baseline. (3) New/recurrent splenomegaly. (4) New/clear progression of preexisting nonmeasured lesions. (5) Regrowth of previously resolved lesions. (6) A new node > 1.5 cm in any axis. (7) A new extranodal site > 1.0 cm in any axis; if < 1.0 cm in any axis, its presence must be unequivocal/attributable to lymphoma. (8) Assessable disease of any size unequivocally attributable to lymphoma. (9) New or recurrent involvement of the bone marrow.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=5 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 2: Duration of Response (DOR): Time From the First Overall Response Contributing to an Objective Response (CR or PR) to the Earlier of the Participant's Death and the First Overall Response of Progressive Disease, Per the Lugano Classification	—	—	8.80 months Interval 1.94 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.

SECONDARY outcome

Timeframe: up to 1538 days

Population: ITT Population. Participants who achieved a CR or a PR per Lugano Classification were analyzed. The confidence interval was calculated based on the exact method for binomial distribution.

DRR=percentage of participants with a CR or PR, per Lugano Classification, for ≥16 weeks since the time from the first overall response contributing to an objective response (CR or PR). CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the LDi; (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; if lesion is too small to measure on computed tomography, assign 5 mm × 5 mm as default; if no longer visible, 0 mm × 0 mm. For node >5 mm × 5 mm but smaller than normal, use actual measurement; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=5 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 2: Durable Response Rate (DRR)	—	—	60.0 percentage of participants Interval 18.93 to 92.36

SECONDARY outcome

Timeframe: up to 1538 days

Population: ITT Population. The 90% confidence interval was calculated using the Brookmeyer and Crowley's method.

Disease progression requires ≥1 of the following: (1) an abnormal individual node/lesion with all of the following: (a) LDi > 1.5 cm; (b) increase by ≥50% from cross product of the LDi and the perpendicular diameter (PPD) nadir; (c) increase in LDi or the shortest axis perpendicular to the LDi (SDi) from nadir: (i) 0.5 cm for lesions ≤2 cm; (ii) 1.0 cm for lesions > 2 cm. (2) For splenomegaly, the splenic length must increased by 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, must increase by at least 2 cm from baseline. (3) New/recurrent splenomegaly. (4) New/clear progression of preexisting nonmeasured lesions. (5) Regrowth of previously resolved lesions. (6) A new node > 1.5 cm in any axis. (7) A new extranodal site > 1.0 cm in any axis; if < 1.0 cm in any axis, its presence must be unequivocal/attributable to lymphoma. (8) Assessable disease of any size unequivocally attributable to lymphoma. (9) New or recurrent involvement of the bone marrow.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=19 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 2: Progression-free Survival (PFS), Defined as the Time From the First Dose to the Earlier Date of Death Due to Any Cause or Disease Progression Determined by Objective Radiographic Disease Assessments	—	—	3.17 months Interval 1.38 to 7.1

SECONDARY outcome

Timeframe: up to 1573 days

Population: Safety Evaluable Population: all participants enrolled in the Phase 2 portion of the study who received at least 1 dose of study drug

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 30 days after the last dose of study drug.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=19 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 2: Number of Participants With Any TEAE	—	—	19 Participants

SECONDARY outcome

Timeframe: up to 1573 days

Population: Safety Evaluable Population

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 30 days after the last dose of study drug. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

Outcome measures

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 1; Cohort 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phase 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=19 Participants Participants received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.
Phase 2: Number of Participants With Any Grade 3 or Higher TEAE	—	—	16 Participants

Adverse Events

Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Phases 1 and 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD

Serious events: 18 serious events

Other events: 26 other events

Deaths: 19 deaths

Total

Serious events: 22 serious events

Other events: 32 other events

Deaths: 21 deaths

Serious adverse events

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 participants at risk Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phases 1 and 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=26 participants at risk Participants in Cohort 2 of Phase 1 and in Phase 2 received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Total n=32 participants at risk Total
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Bacteraemia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Breast cellulitis	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Cytomegalovirus viraemia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Device related infection	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Fatigue	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.4% 4/26 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Gastric ulcer	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Gastroenteritis	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Vascular disorders Haematoma	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Impetigo	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Influenza	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Psychiatric disorders Mental status changes	33.3% 2/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Multiple organ dysfunction syndrome	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Nausea	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Injury, poisoning and procedural complications Postoperative respiratory failure	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Pyrexia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Sepsis	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Staphylococcal sepsis	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Transaminases increased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Ear and labyrinth disorders Vestibular disorder	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).

Other adverse events

Measure	Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD n=6 participants at risk Participants received oral itacitinib 300 milligrams (mg) once daily (QD) plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Phases 1 and 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD n=26 participants at risk Participants in Cohort 2 of Phase 1 and in Phase 2 received oral itacitinib 400 mg QD plus oral ibrutinib 560 mg QD until treatment discontinuation criteria were met.	Total n=32 participants at risk Total
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Alanine aminotransferase increased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	26.9% 7/26 • Number of events 7 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	28.1% 9/32 • Number of events 9 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Anal incontinence	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Asthenia	33.3% 2/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Blood cholesterol increased	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Blood creatinine increased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Cheilitis	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Chills	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Renal and urinary disorders Chronic kidney disease	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Psychiatric disorders Confusional state	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	34.6% 9/26 • Number of events 9 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	34.4% 11/32 • Number of events 12 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	26.9% 7/26 • Number of events 8 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	21.9% 7/32 • Number of events 8 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	19.2% 5/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	21.9% 7/32 • Number of events 7 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	34.6% 9/26 • Number of events 10 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	31.2% 10/32 • Number of events 11 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	19.2% 5/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.6% 5/32 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	34.6% 9/26 • Number of events 14 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	34.4% 11/32 • Number of events 16 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Psychiatric disorders Disorientation	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	26.9% 7/26 • Number of events 7 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	25.0% 8/32 • Number of events 8 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Nervous system disorders Dizziness postural	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	26.9% 7/26 • Number of events 8 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	25.0% 8/32 • Number of events 9 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Eye disorders Eye irritation	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.4% 4/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Fatigue	50.0% 3/6 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	46.2% 12/26 • Number of events 15 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	46.9% 15/32 • Number of events 18 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Vascular disorders Haematoma	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Nervous system disorders Headache	16.7% 1/6 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 7 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Vascular disorders Hypertension	16.7% 1/6 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Vascular disorders Hypotension	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.4% 4/26 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Injection site bruising	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Psychiatric disorders Insomnia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Joint swelling	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Lymphocyte count decreased	16.7% 1/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Muscle tightness	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	19.2% 5/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.6% 5/32 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Nausea	33.3% 2/6 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	26.9% 7/26 • Number of events 10 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	28.1% 9/32 • Number of events 12 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Neutrophil count decreased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Oedema peripheral	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.4% 4/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Pain	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Cardiac disorders Palpitations	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Investigations Platelet count decreased	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.4% 4/26 • Number of events 7 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 7 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Renal and urinary disorders Pollakiuria	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
General disorders Pyrexia	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	23.1% 6/26 • Number of events 6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	18.8% 6/32 • Number of events 6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Skin infection	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	15.4% 4/26 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 5 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	7.7% 2/26 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Ear and labyrinth disorders Tinnitus	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Tongue eruption	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Nervous system disorders Tremor	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.8% 1/26 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	6.2% 2/32 • Number of events 2 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Urinary tract infection	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Eye disorders Vision blurred	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	12.5% 4/32 • Number of events 4 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Gastrointestinal disorders Vomiting	0.00% 0/6 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	11.5% 3/26 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	9.4% 3/32 • Number of events 3 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).
Infections and infestations Wound infection pseudomonas	16.7% 1/6 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	0.00% 0/26 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).	3.1% 1/32 • Number of events 1 • Phase 1 participants were monitored for up to 285 days. Phase 2 participants were monitored for up to 1573 days. Treatment-emergent adverse events (AEs reported for the first time or the worsening of pre-existing AEs after the first dose and until 30 days after the last dose of study drug) are reported for members of the Phase 1 Safety Run-In Population and the Phase 2 Safety Evaluable Population (all enrolled participants who received ≥1 dose of study drug).

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER